A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715101
FDA Recall Z-1221-2025 · Posted 2025-02-21
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Recalling FirmTyber Medical
Recall StatusOpen, Classified
Product CodeHRS
Date Initiated2025-01-21
Product Quantity200 units
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
Firm Action
Tyber Medical issued Urgent Medical Device Recall letter on 1/24/25 via email to the Distributor. Letter states reason for recall, health risk and action to take:
1. Acknowledge the receipt of this communication via email correspondence to [email protected].
2. Further distribute this communication to all applicable parties and/or customers that possess the impacted inventory.
3. Identify via laser-marked lot number and quarantine the impacted plates under Zimmer Biomet s control that have not been distributed for sale. An RMA will be provided for the return of goods to Tyber Medical for further inspection.
4. Identify via laser-marked lot number and quarantine the impacted plates that have been distributed. An RMA will be provided for the return of goods to Tyber Medical for further inspection.
5. Complete the customer response form located in Appendix 2 and return it to Tyber Medical via email correspondence to [email protected].
Root Cause
Process control
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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