FDAClass IIMarch 5, 2025

A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic recall

A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770708102 Product Description:

Why was A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H 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 00196449015597; Lot Numbers 265810, 260892, 262559

Product
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770708102 Product Description:
Recalling firm
Tyber Medical
Quantity
219 units
Distribution
Nationwide
Recall date
March 5, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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