The Recall Desk
HighFDA (Devices)·Z-1400-2023·Announced 2023-04-26

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

Medacta Usa Inc is recalling the MectaLIF ANTERIOR Lag Plate Flush H10 interbody fusion device due to a potential risk of screw breakage in the anti-backout plate. No injuries have been reported.

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 where potential structural failure has not yet resulted in reported injuries. Although this is an FDA Class II device, no hospitalizations or actual injuries have been reported. The potential screw breakage in a critical spinal implant component meets the criteria for a score of 3.

Plain-English summary

The FDA has issued a recall for the MectaLIF ANTERIOR - Lag Plate Flush H10 (REF 03.30.300) interbody fusion device manufactured by Medacta Usa Inc. The device is used in spinal fusion surgery to help stabilize the spine and promote bone fusion between vertebrae.

The recall has been initiated due to a potential risk of breakage in the small screw that affixes the anti-backout plate. If this screw were to break, it could affect the device's structural integrity and function in the spine.

The recall affects 32 units distributed in the United States across Idaho, Texas, Georgia, Virginia, and Arizona. All lot numbers of the device are included in this recall.

Patients who have received this device should consult their healthcare provider. Medacta Usa Inc recommends that healthcare providers review the recall information and monitor patients with this implant for any signs of device malfunction.

The recalled product

Product
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
Manufacturer
Medacta Usa Inc
Category
Medical Device — Spinal Fusion Implant
Hazard
Affected units
32

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 07630345732286
  • 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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