TSP Hip Fracture Plating System device — Class II medical device recall Z-2240-2016
Terminated recall by Biomet, Inc., reported 2016-07-27, distributed nationwide. The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a
| Recall number | Z-2240-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-06-10 |
| Classified | 2016-07-19 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2017-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, JP, NL |
| Quantity | 5,458 units |
| Reason classes | foreign material, device malfunction |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2240-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.