Z-1212-2025 Class II Ongoing
FDA device recall Z-1212-2025 was initiated by Tyber Medical on January 21, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 408.
Recall Details
- Product Type
- Devices
- Report Date
- March 5, 2025
- Initiation Date
- January 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 408
Product Description
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
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 Pattern
Nationwide
Code Information
UDI-DI 00196449015559; Lot Numbers 265783, 267847, 24036BU02, 261289