The Recall Desk
HighFDA (Devices)·Z-1215-2025·Announced 2025-03-05

Anatomic Lateral Fibula Plate locking screw malfunction during surgery

Tyber Medical is recalling 220 A.L.P.S. mvX Anatomic Lateral Fibula Plates due to complaints that the locking screw passes through the locking hole during surgery, causing surgical delays.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with a documented malfunction that occurs during critical surgical procedures. However, no injuries or hospitalizations have been reported; the documented impact is surgical delays. The potential for harm exists in a high-risk context, but actual harm has not manifested.

Plain-English summary

Tyber Medical is recalling 220 units of the A.L.P.S. mvX Anatomic Lateral Fibula Plate, 10-hole, left-sided model (Model/Catalog Number 770708101; Lot Numbers 269171, 265809, 262558, 260891; UDI-DI 00196449015580). The malfunction described in this recall also affects A.L.P.S. mvX Medial Tibia plates. These orthopedic devices are intended for fixation of fractures of the distal tibia.

The FDA received complaints of the locking screw passing through the locking hole during intraoperative use. Surgical delays have been reported with use of these devices.

The affected devices were distributed nationwide. This is classified as a Class II recall by the FDA.

The recalled product

Product
A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770708101
Manufacturer
Tyber Medical
Category
Medical Device — Orthopedic Fixation
Hazard
Affected units
220

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • UDI-DI 00196449015580
  • Lot Numbers 269171
  • 265809
  • 262558
  • 260891

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by Tyber Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

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Same hazard · locking failure

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