FDA Device recall Z-2058-2015
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw by Biomet, citing sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2058-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-04 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | n/a |
Product
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Reason
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Identifiers
| code_info | Part number:856135060 Lot: 061300 |
|---|
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-2058-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.