TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating…
Medical device recall Z-2240-2016. Published in FDA’s Enforcement Report on Jul 27, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 27, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 5458 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies
5458 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All Lots. Part Number / Description: 14-451002 130 DEG 2-HOLE LEFT NECK FX 14-451004 130 DEG 4-HOLE LEFT NECK FX 14-451070 7.5MM TELESCOPE LAG SCR 70MM 14-451075 7.5MM TELESCOPE LAG SCR 75MM 14-451080 7.5MM TELESCOPE LAG SCR 80MM 14-451085…
Every code shown here, 1,991 characters
All Lots. Part Number / Description: 14-451002 130 DEG 2-HOLE LEFT NECK FX 14-451004 130 DEG 4-HOLE LEFT NECK FX 14-451070 7.5MM TELESCOPE LAG SCR 70MM 14-451075 7.5MM TELESCOPE LAG SCR 75MM 14-451080 7.5MM TELESCOPE LAG SCR 80MM 14-451085 7.5MM TELESCOPE LAG SCR 85MM 14-451090 7.5MM TELESCOPE LAG SCR 90MM 14-451095 7.5MM TELESCOPE LAG SCR 95MM 14-451100 7.5MM TELESCOPE LAG SCR 100MM 14-451102 130 DEG 2-HOLE RIGHT NECK FX 14-451104 130 DEG 4-HOLE RIGHT NECK FX 14-451105 7.5MM TELESCOPE LAG SCR 105MM 14-451110 7.5MM TELESCOPE LAG SCR 110MM 14-451115 7.5MM TELESCOPE LAG SCR 115MM 14-451120 7.5MM TELESCOPE LAG SCR 120MM 14-451125 7.5MM TELESCOPE LAG SCR 125MM 14-451130 7.5MM TELESCOPE LAG SCR 130MM 14-451500 ANGLE GUIDE 130 DEG 14-451502 GUIDE WIRE 3.0MM 14-451503 GUIDE PIN DRIVER 3.0MM 14-451504 TARGETING GUIDE 130 DEG LEFT 14-451505 TARGETING GUIDE 130 DEG RIGHT 14-451509 JIG ATTACHMENT DRIVER 3.5MM 14-451510 NON-LOCK GUIDE SLEEVE 7.5MM 14-451511 LOCKING GUIDE SLEEVE 7.5MM 14-451512 ENTRY TROCAR 7.5 MM 14-451513 DRILL BIT 3.0MM 14-451525 GUIDE WIRE DEPTH GAUGE 3.0MM 14-451526 STEP DRILL CANNULATED 7.5MM 14-451527 STEP DRILL NON-CANN 7.5MM 14-451528 TSP HIP FX TAP 7.5MM 14-451529 HEX DRIVER NECK SLEEVE 5.0MM 14-451530 DRIVER CONNECTOR SHAFT 5.0MM 14-451531 HEX DRIVER NECK SHAFT 3.5MM 14-451532 INSERTER LIMITED COLLAPSE 14-451533 DEPTH GAUGE LIMITED COLLAPSE 14-451535 SCREW GUIDE SLEEVE 4.5MM 14-451536 TROCAR 4.5MM SCREW 14-451537 DRILL GUIDE LOCKING 3.5MM 14-451538 DRILL GUIDE NON-LOCK 3.5MM 14-451539 DRILL BIT 3.5MM 14-451540 SCREW DEPTH GAUGE 4.5MM 14-451541 SCREW DEPTH GAUGE HOOK 4.5MM 14-451542 TSP HIP FX CORTICAL TAP 4.5MM 14-451543 DRIVER 5.0 HEX/3.5 HEXALOBE 14-451544 CONNECTOR SHAFT 4.5MM SCREW 14-451546 T HANDLE W/ HUDSON 14-451550 IMPACTION HANDLE 14-451551 IMPACTION GUIDE PAD 14-451552 IMPACTION PLATE PAD 14-451554 GUIDE WIRE ALIGNMENT ARM 14-451560 GUIDE WIRE PUSHER 2.8MM 14-451561 GUIDE WIRE PLACEMENT TROCAR 14-451562 GUIDE WIRE PLACEMENT SLEEVE…
FDA’s list runs to 4,785 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US (Nationwide) Internationally to Australia, The Netherlands, and Japan
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 10, 2016.
- FDA classified it on Jul 19, 2016.
- FDA’s Enforcement Report published it on Jul 27, 2016.
- FDA terminated it on Jul 20, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Biomet, Inc., of Warsaw, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,785 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
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.” Copied on Oct 20, 2026.