FDA Enforcement
Class II
Ongoing
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Description:
Recall: Z-1218-2025
·
Reported March 5, 2025
Enforcement
- Recall Number
- Z-1218-2025
- Event ID
- 96212
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Tyber Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 5, 2025
- Initiation Date
- January 21, 2025
- Classification Date
- February 21, 2025
- Address
- 83 S Commerce Way Ste 310, N/A, Bethlehem, PA, 18017-8934, United States
Description
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Description:
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
Code Info
UDI-DI 00196449015610; Lot Numbers 262571, 260894
Distribution
Nationwide
Quantity
115 units