The Recall Desk
HighFDA (Devices)·Z-1403-2023·Announced 2023-04-26

FDA Recalls MectaLIF ANTERIOR Interbody Fusion Device Due to Screw Breakage Risk

Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device due to potential breakage of the small screw that affixes the anti-backout plate. The recall affects 34 units distributed in the United 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 an FDA Class II medical device recall for a potential structural defect (screw breakage) in a spinal implant. No injuries, hospitalizations, or deaths are reported in the source text. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Medacta Usa Inc is recalling the MectaLIF ANTERIOR Lag Plate Flush H16 (REF 03.30.303), an interbody fusion device used in spinal surgery. The device is identified by UDI/DI 07630345732316 across all lot numbers.

The recall was initiated due to a potential for breakage of the small screw used to affix the anti-backout plate. A failure of this screw could compromise the integrity and function of the implant.

The recalled devices were distributed across five U.S. states: Idaho, Texas, Georgia, Virginia, and Arizona, affecting 34 total units.

The recalled product

Product
MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
Manufacturer
Medacta Usa Inc
Category
Medical Device — Spinal Implant
Hazard
Affected units
34

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 07630345732316
  • 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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