FDA Medical devices recall ·
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula… recall
- Recall number
- Z-1218-2025
- Date
- (initiated January 21, 2025)
- Company / brand
- Tyber Medical
83 S Commerce Way Ste 310, Bethlehem, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 115 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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:
Why was it recalled?
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 00196449015610; Lot Numbers 262571, 260894
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1218-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.