TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are
FDA device recall Z-2240-2016 · posted 2016-07-19 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 10, 2016, to all affected customers via courier. Distributors and hospitals were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-6725, Monday through Friday, 8 a.m. to 5 p.m.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JDO
- Quantity affected
- 5458 units
- Distribution
- Worldwide Distribution - US (Nationwide) Internationally to Australia, The Netherlands, and Japan
- Date initiated
- 2016-06-10
- Date posted
- 2016-07-19
- Date terminated
- 2017-07-20
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TSP HIP FRACTURE PLATING SYSTEM (K140018) | Biomet, Inc. | 2014-04-04 |