Data Foundry

Medical device recalls 2025

A — Class II medical device recall Z-1220-2025

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 numberZ-1220-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmTyber Medical, Bethlehem, PA, United States
Recall initiated2025-01-21
Classified2025-02-21
Reported by FDA2025-03-05
DistributedNationwide (US)
Quantity210 units
UPC / GTIN / UDI-DI00196449015986
Lot numbers24052DF01, 24053DF01, 24065DF06, 265792
Model numbers770715062

Product

A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the distal tibia

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-1220-2025. 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.