A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal
FDA device recall Z-1226-2025 · posted 2025-02-21 · Open, Classified
Recall details
- Recalling firm
- Tyber Medical
- 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
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HRS
- Quantity affected
- 109 units
- Distribution
- Nationwide
- Date initiated
- 2025-01-21
- Date posted
- 2025-02-21
- Location
- Bethlehem, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Anatomical Plating System (various) (K232652) | Tyber Medical, LLC | 2023-12-13 |