PlainRecalls
FDA Devices Moderate Class II Ongoing

A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121

Reported: March 5, 2025 Initiated: January 21, 2025 #Z-1223-2025

Product Description

A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121

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

Details

Recalling Firm
Tyber Medical
Units Affected
201 units
Distribution
Nationwide
Location
Bethlehem, PA

Frequently Asked Questions

What product was recalled?
A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121. Recalled by Tyber Medical. Units affected: 201 units.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on March 5, 2025. Severity: Moderate. Recall number: Z-1223-2025.