Tyber Medical: Device Recall
Recall #Z-1213-2025 · 01/21/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1213-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Tyber Medical
- Status
- Ongoing
- Date Initiated
- 01/21/2025
- Location
- Bethlehem, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 214 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
Product Description
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 770708081
Distribution Pattern
Nationwide
Other Recalls by Tyber Medical
- Class II: Risk 12/19/2025
- Class II: Risk 12/19/2025
- Class II: Risk 01/21/2025
- Class II: Risk 01/21/2025
- Class II: Risk 01/21/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.