A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715161
- Company
- Tyber Medical
- Recall Initiated
- January 21, 2025
- Posted
- February 21, 2025
- Recall Number
- Z-1225-2025
- Quantity
- 100 units
- Firm Location
- Bethlehem, PA
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
Distribution
Nationwide
Lot / Code Info
UDI-DI 00196449016037; Lot Numbers 24061DF01, 24065DF02, 24070DF01
Root Cause
Process control
Action Taken
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 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 feedback@tybermed.com.