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A.L.P.S. mvX recallZ-1224-2025 · Tyber Medical · initiated Jan 21, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Tyber Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Process control

What the company is doing

Tyber Medical issued Urgent Medical Device Recall letter on 1/24/25 via email to the Distributor. Letter states reason for recall, health risk and action to take: 1. Acknowledge the receipt of this communication via email correspondence to [email protected]. 2. Further distribute this communication to all applicable parties and/or customers that possess the impacted inventory. 3. Identify via laser-marked lot number and quarantine the impacted plates under Zimmer Biomet s control that have not been distributed for sale. An RMA will be provided for the return of goods to Tyber Medical for further inspection. 4. Identify via laser-marked lot number and quarantine the impacted plates that have been distributed. An RMA will be provided for the return of goods to Tyber Medical for further inspection. 5. Complete the customer response form located in Appendix 2 and return it to Tyber Medical via email correspondence to [email protected].

Recall details

Recall number
Z-1224-2025
Status
Open, Classified
Initiated by the company
Jan 21, 2025
Posted by the FDA
Feb 21, 2025
Recalling firm
Tyber Medical
Quantity
208 units
Product code
HRS
FDA submissions
K232652
Distribution
Nationwide

Product description

A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122

Code information (models, lots, serial numbers)

UDI-DI 00196449016020; Lot Numbers 265817, 24060DF08, 263511, 24057DF02, 24057DF04

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96212).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page