FDAClass IIMarch 5, 2025

A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic recall

A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Description:

Why was A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic 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 00196449015610; Lot Numbers 262571, 260894

Product
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Description:
Recalling firm
Tyber Medical
Quantity
115 units
Distribution
Nationwide
Recall date
March 5, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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