A — Class II medical device recall Z-1214-2025
Ongoing recall by Tyber Medical, reported 2025-03-05, distributed nationwide. Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S.
| Recall number | Z-1214-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tyber Medical, Bethlehem, PA, United States |
| Recall initiated | 2025-01-21 |
| Classified | 2025-02-21 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 212 units |
| UPC / GTIN / UDI-DI | 00196449015573 |
| Lot numbers | 24036BU01, 261291, 265785 |
| Model numbers | 77070802 |
Product
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
Reason for recall
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
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-1214-2025. 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.