The Recall Desk
HighFDA (Devices)·Z-1402-2023·Announced 2023-04-26

Medacta MectaLIF ANTERIOR spine implant recalled due to screw breakage risk

Medacta USA is recalling MectaLIF ANTERIOR interbody fusion devices due to a potential for breakage of a small screw that secures the anti-backout plate. The defect affects 44 units distributed across five 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: FDA Class II device with a potential structural failure (screw breakage) on a surgical implant. No hospitalizations or injuries reported, but the hazard poses a risk of device malfunction.

Plain-English summary

Medacta USA Inc is recalling the MectaLIF ANTERIOR - Lag Plate Flush H14 (REF 03.30.302), an interbody fusion device used in spinal surgery. The device is identified by UDI/DI 07630345732309 and includes all lot numbers.

The recall has been issued because there is a potential for breakage of the small screw used to affix the anti-backout plate. This structural failure could compromise the device's stability.

The recall affects 44 units distributed to medical facilities in Idaho, Texas, Georgia, Virginia, and Arizona. Patients who have received this implant should consult their healthcare provider if they have concerns.

Healthcare providers and patients with questions should contact Medacta USA Inc. No injuries or illnesses have been reported to date.

The recalled product

Product
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
Manufacturer
Medacta Usa Inc
Category
Medical Device — Spinal Fusion Implant
Hazard
Affected units
44

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 07630345732309
  • 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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