Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Assembly, Radial Head Implant, Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Assembly, Radial Head Implant, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Assembly, Radial Head Implant, Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Assembly, Radial Head Impl Assembly, Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Assembly, Radial Head Impl Assembly, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Assembly, Radial Head Impl Assembly, Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Stem Implant Plasma Coated, Size 1 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Stem Implant Plasma Coated, Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Stem Implant Plasma Coated, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Stem Implant Plasma Coated, Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Stem Implant 6mm Collar, Size 1 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Stem Implant 6mm Collar, Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Stem Implant 6mm Collar, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of the proximal end of the radius in… Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant Plasma Coated, Size 1 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant Plasma Coated, Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant Plasma Coated, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant Plasma Coated, Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant 6mm Collar,Size 1 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant 6mm Collar, Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant 6mm Collar, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant 6mm Collar, Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the… Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radio Capitellum Small, Left Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radio Capitellum Large, Right Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radio Capitellum Small, Right Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radial Head Assy Size #2, Rad Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radial Head Assy Size #3, Rad Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radial Head Assy Size #4, Rad Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radio Capitellum, Recon Head, Size #2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radio Capitellum, Recon Head, Size #3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radio Capitellum, Recon Head, Size #4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Standard Extended Stem, 6mm Collar, Size 1 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Standard Extended Stem, 6mm Collar, Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Standard Extended Stem, 6mm Collar, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Standard Extended Stem, 6mm Collar, Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Extended Stem Size 1 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Extended Stem Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Extended Stem Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radio Capitellum Broach Large, Right Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall #2 Bipolar radial head Implant (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall #3 Bipolar radial head Implant (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall #4 Bipolar radial head Implant (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall #1 Bipolar stem implant (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant non-coated, Size 1 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass 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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