FDA Device recall Z-2046-2015
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right
- FDA Device
- Class II
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class II recall of A.L.P.S. Foot Locking Calcaneus Plate,Small-Right by Biomet, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2046-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-04 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | AR, AZ, FL, GA, MA, MD, NC, NJ, PA, TX |
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
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.
Identifiers
| code_info | Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2046-2015%22
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