The Recall Desk
HighFDA (Devices)·Z-1405-2023·Announced 2023-04-26

Spinal fusion device antibackout screw may break, FDA recalls

Medacta Usa Inc is recalling MectaLIF ANTERIOR antibackout lag covers due to potential breakage of the small screw that affixes the anti-backout plate. The defect affects spinal fusion procedures in select US states.

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 risk-of-harm medical device (spinal fusion component) with potential mechanical failure (screw breakage). No injuries or failures have been reported in the source. The theoretical nature of the hazard combined with FDA Class II classification supports a High severity rating.

Plain-English summary

Medacta Usa Inc is recalling the MectaLIF ANTERIOR Antibackout Lag Cover (REF 03.30.305), an interbody fusion device component used in spinal surgery. Fifty units were distributed across five US states: Idaho, Texas, Georgia, Virginia, and Arizona. All lot numbers are included in the recall.

The recall addresses a potential for breakage of the small screw used to affix the anti-backout plate. The FDA has classified this as a Class II recall. The affected devices can be identified using UDI/DI 07630345732330.

The recalled product

Product
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Manufacturer
Medacta Usa Inc
Category
Medical Device — Spinal Fusion Device
Hazard
Affected units
50

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 (2)

  • UDI/DI 07630345732330
  • All Lot Numbers

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 6 recalled by Medacta Usa Inc 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 6 products in this recall →

Related recalls

Same manufacturer · Medacta Usa Inc

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Same hazard · screw breakage

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