A — Class II medical device recall Z-2046-2015
Terminated recall by Biomet, Inc., reported 2015-07-15, distributed in AR, AZ, FL, GA, MA, MD, NC, NJ…. The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are t
| Recall number | Z-2046-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-06-04 |
| Classified | 2015-07-08 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2015-12-22 |
| Distributed | AR, AZ, FL, GA, MA, MD, NC, NJ, PA, TX |
| Countries outside the US | CR, NL |
| Quantity | 75 units |
| Lot numbers | 015840, 124980, 948210, P0059, P0061, P0076 |
| Model numbers | 816209001 |
Product
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Reason for recall
The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper purchase. This may require a revision surgery to replace or remove the screw and/or plate. The threads, not uniformly loaded, may shear off, causing metal slivers.
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-2046-2015. 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.