Medical device recalls Moderate risk

Tyber Medical recalls A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fr…

Recall date
January 21, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1217-2025
FDA classification
Class II
Brand / firm
Tyber Medical
Sold / distributed
Nationwide

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708121

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