Agency classClass IIOur severity:High FDA (Devices)·Z-1216-2025·Announced 2025-03-05

Anatomic lateral fibula plate locking screw failure during surgery

Tyber Medical A.L.P.S. mvX anatomic lateral fibula plates (219 units nationwide) have a defect where the locking screw can pass through its locking hole during surgery, causing surgical delays.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II device with no reported injuries or illnesses. The locking screw malfunction during surgery represents a risk of harm during operative procedures, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The Tyber Medical A.L.P.S. mvX Anatomic Lateral Fibula Plate (Model 770708102) is subject to a Class II FDA recall. This orthopedic fixation device is intended for fixation of fractures of the distal tibia. A total of 219 units have been distributed nationwide.

Complaints have been received that the locking screw can pass through the locking hole during intraoperative use. This mechanical defect has caused surgical delays. The affected lot numbers are 265810, 260892, and 262559 (UDI-DI 00196449015597).

Healthcare facilities and providers should check for affected units and contact Tyber Medical for recall instructions. Patients and providers should consult with their healthcare team regarding any questions or concerns about this device.

The recalled product

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:
Manufacturer: Tyber Medical
Category: Medical Device — Orthopedic / Fracture Fixation
Hazard: mechanical-failure
surgical-delay
Affected units: 219

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 (4)

UDI-DI 00196449015597
Lot Numbers 265810
260892
262559

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 →

Same manufacturer · Tyber Medical

See all →

Moderate
Long distal radius plates recalled over an incorrect thread orientation
FDA (Devices) · 2026-01-28
Moderate
Distal radius plates recalled over an incorrect thread orientation
FDA (Devices) · 2026-01-28
High
Medical plate locking screw may fail during fracture surgery
FDA (Devices) · 2025-03-05
High
Orthopedic Tibia Plate Locking Screw Malfunction Nationwide Recall
FDA (Devices) · 2025-03-05
High
Medial tibia plate screw locking defect causes surgical delays
FDA (Devices) · 2025-03-05

Same hazard · mechanical failure