FDAClass IIMarch 5, 2025

A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia recall

A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalog Number…

Why was A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia 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 I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI 00196449016044; Lot Numbers 24053DF02, 24070DF02, 24057DF01

Product
A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalog Number…
Recalling firm
Tyber Medical
Quantity
109 units
Distribution
Nationwide
Recall date
March 5, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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