Agency classClass IIOur severity:High FDA (Devices)·Z-1213-2025·Announced 2025-03-05

Orthopedic plate recall: locking screw may pass through hole during surgery

Tyber Medical is recalling 214 units of A.L.P.S. mvX orthopedic plates (nationwide) because the locking screw may pass through the locking hole during surgery. Surgical delays 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: This is a Class II recall for an orthopedic implant with documented mechanical failure during surgery. The source text reports surgical delays but does not indicate any reported injuries, hospitalizations, or deaths, placing it within the High severity tier for risk-of-harm products without yet-reported injury.

Plain-English summary

Tyber Medical is recalling 214 units of A.L.P.S. mvX Anatomic Lateral Fibula Plate, 8-hole, Left (Model/Catalog Number 770708081), an orthopedic implant intended to stabilize bone fragments during healing. The product is distributed nationwide. Affected units are identified by UDI-DI 00196449015566 and lot numbers 265784, 24043BU01, and 261290.

The recall was initiated because the locking screw can pass through the locking hole during surgery (intra-operatively). This device malfunction has been documented in multiple complaints received by the manufacturer and FDA.

Patients who have received or are scheduled to receive this implant should contact their surgeon or healthcare provider immediately. Healthcare facilities should check their inventory for the affected lot numbers and take appropriate action. Surgical delays have been reported as a result of this defect.

The recalled product

Product: A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 770708081
Manufacturer: Tyber Medical
Category: Medical Device — Orthopedic / Surgical Implant
Hazard: mechanical-failure
device-malfunction
Affected units: 214

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 00196449015566
Lot Numbers 265784
24043BU01
261290

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

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Same hazard · mechanical failure