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FDA (Device enforcement)Recalled 2025-01-21class ii

Tyber Medical: 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

Hazard

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 from the source

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 Distribution: Nationwide Quantity: 201 units Lot/code info: UDI-DI 00196449016013; Lot Numbers 265816, 24064DF01, 263557, 24065DF04, 24059DF03, 24059DF02

UPC codes

00196449016013

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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