Recall Z-1219-2025 ยท HRS Plate, Fixation, Bone
Tyber Medical
A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715061
| Date | Feb 21, 2025 (initiated Jan 21, 2025) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process control |
| 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 feedback@tybermed.com. 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 |
| Quantity | 197 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232652 | Anatomical Plating System (various) Tyber Medical, LLC, Dec 13, 2023 |