Medical device recalls Moderate risk

Tyber Medical recalls A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for F…

Recall date
January 21, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1220-2025
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- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the distal tibia

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