Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is… Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Florida, Illinois, Michigan, South Carolina and Texas named
- Medical device recall “***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF… Potential for bent tips. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Delaware, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New York and Pennsylvania
- Medical device recall “***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF… Potential for bent tips. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Delaware, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New York and Pennsylvania
- Medical device recall “***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF… Potential for bent tips. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Delaware, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New York and Pennsylvania
- Medical device recall “***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF… Potential for bent tips. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Delaware, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New York and Pennsylvania
- Medical device recall Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130¿C. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI Philips Medical Systems Cleveland), Inc. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Maine, Michigan, New York and Wisconsin named
- Medical device recall Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally… A complaint received from sales representative that a replenishment instrument was too short. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Florida, Georgia, Illinois, Kentucky, Michigan, North Carolina, New York and Texas named
- Medical device recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alloclassic SL Shaft Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biolox¿ delta Ceramic Femoral Head Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biolox¿ Option Ceramic Femoral Head System Rx, sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wagner SL Revision Stem, uncemented Sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alloclassic¿ SL-Offset Stem sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Metasul¿ LDH¿ Head Rx Sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Metasul¿ Durom¿ Femoral component Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MS-30¿ Stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MS-30¿ Distal centralizer, cemented, sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MS-30¿ Proximal positioner Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fitmore” Hip Stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wagner cone Prosthesis, uncemented, sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoCr Head, sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anatomical Shoulder” Humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anatomical Shoulder” Fracture Humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anatomical Shoulder” Humeral Head Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall zimmer Anatomical Shoulder Glenoid S, cemented, sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anatomical Shoulder” Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Inverse/Reverse Screw system Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anatomical Shoulder” Inverse Humeral Cup Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anatomical Shoulder” Inverse/Reverse Glenoid Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anatomical Shoulder” Inverse/Reverse Humeral PE-Insert Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anatomical Shoulder” Ball taper for humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anatomical Shoulder” Fracture Humeral Head Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLS Stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Original M.E Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dynesys¿ Set screw M6 Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dynesys¿ Universal spacer 6-45 Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dynesys¿ L.I.S Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dynesys¿ Revision + set screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dynesys¿ HA Pedicle + set screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DTO” Implant Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NCB¿ cancellous screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NCB¿ screw ¿ 4.0 self-tapping Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NCB¿-PT lateral proximal 3 hole tibial plate Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NCB¿-PH Plate Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sirus¿ intramedullary nail for tibia, cannulated ¿ Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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