Agency classClass IIOur severity:High FDA (Devices)·Z-1224-2025·Announced 2025-03-05

A.L.P.S. mvX Medial Tibia Plate Locking Screw Malfunction Recall

Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.

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 recall involving a surgical implant where the locking mechanism can malfunction intra-operatively, causing surgical delays. No patient injuries or deaths have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Tyber Medical is recalling 208 units of the A.L.P.S. mvX Medial Tibia Plate, 12-Hole, Right (Model/Catalog Number 770715122), a surgical implant intended for fixation of distal tibia fractures.

The recall stems from complaints that the locking screw can pass through the locking hole during intra-operative use. This malfunction has resulted in surgical delays. No patient injuries or illnesses have been reported.

The affected devices were distributed nationwide across lot numbers 265817, 24060DF08, 263511, 24057DF02, and 24057DF04 (UDI-DI 00196449016020).

Surgeons and healthcare providers with these devices should contact Tyber Medical for guidance on replacement or further instructions regarding this recall.

The recalled product

Product: 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
Manufacturer: Tyber Medical
Category: Medical Device — Orthopedic Implant
Hazard: locking-mechanism-failure
surgical-delay
Affected units: 208

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 (6)

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

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 · locking mechanism failure