The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1404-2023·Announced 2023-04-26

Interbody Fusion Device Recalled for Potential Screw Breakage

Medacta's MectaLIF ANTERIOR fusion device is being recalled due to potential breakage of a small screw used to affix the anti-backout plate. The recall affects 17 units distributed across the US.

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 of an interbody fusion medical device where screw breakage could result in serious harm. While no injuries have been reported in the source text, the risk-of-harm nature of a structural failure in such a device warrants a High severity classification.

Plain-English summary

Medacta USA Inc has recalled the MectaLIF ANTERIOR - Lag Plate Flush H18 (REF 03.30.304), an interbody fusion device. The recall is due to a potential for breakage of the small screw used to affix the anti-backout plate.

Affected units have UDI/DI 07630345732323 across all lot numbers. The recall involves 17 units that were distributed to facilities in Idaho, Texas, Georgia, Virginia, and Arizona.

Patients who have received this device or healthcare providers who have implanted these devices should consult with Medacta USA Inc or their healthcare provider regarding this potential risk. Further information regarding product inspections or device management should be directed to the manufacturer.

The recalled product

Product
MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
Manufacturer
Medacta Usa Inc
Category
Medical Device — Spinal Implant
Hazard
Affected units
17

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 07630345732323
  • 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 →

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