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.
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: 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
- 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
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
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