Agency classClass IIOur severity:High FDA (Devices)·Z-1222-2025·Announced 2025-03-05

Orthopedic Tibia Plate Locking Screw Malfunction Nationwide Recall

Tyber Medical is recalling 209 A.L.P.S. mvX Medial Tibia plates nationwide due to reports that locking screws can pass through the 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: This is an FDA Class II recall involving a device malfunction (locking screw passing through the locking hole) that presents risk of surgical complications. However, the source text does not report any injuries, hospitalizations, or patient harm—only surgical delays. Per the rubric, this corresponds to score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Tyber Medical is recalling 209 units of the A.L.P.S. mvX Medial Tibia Plate, 10-Hole, Right (Model 770715102). This medical device is designed to fixate fractures of the distal tibia. The recall affects units with lot numbers 265815, 24055DF03, and 24055DF04 that were distributed nationwide.

The device has been recalled due to complaints of the locking screw passing through the locking hole during surgical implantation. This malfunction occurs intra-operatively and has resulted in reported surgical delays during the implantation procedure.

This is an FDA Class II recall. Healthcare providers who may have received or used these devices should verify their inventory against the affected lot numbers.

The recalled product

Product: A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number: 770715102
Manufacturer: Tyber Medical
Category: Medical Device — Orthopedic Surgical Fixation
Hazard: device-malfunction
surgical-complication
Affected units: 209

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 00196449016006
Lot Numbers 265815
24055DF03
24055DF04

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
Distal radius plates recalled over an incorrect thread orientation
FDA (Devices) · 2026-01-28
Moderate
Long 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
Medial tibia plate screw locking defect causes surgical delays
FDA (Devices) · 2025-03-05
High
Tyber Medical recalls A.L.P.S. mvX Anatomic Lateral Fibula Plates due to screw malposition
FDA (Devices) · 2025-03-05

Same hazard · device malfunction