Medacta interbody fusion plate device recalled for screw breakage
Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device because the small screw affixing the anti-backout plate may break, potentially compromising device integrity.
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 medical device recall for a structural defect in a surgical implant where the fastening screw may break. No illnesses or injuries have been reported. Per the rubric, structural defects without reported harm in Class II devices score at most 3 as risk-of-harm products without yet-reported injury.
Plain-English summary
Medacta Usa Inc is recalling the MectaLIF ANTERIOR Lag Plate Flush H12 (REF 03.30.301), an interbody fusion device used in spinal surgery.
The recall was issued because there is a potential for breakage of the small screw used to affix the anti-backout plate on the device.
Approximately 53 units were distributed in the United States across Idaho, Texas, Georgia, Virginia, and Arizona. All lot numbers of the affected device carry UDI/DI 07630345732293.
Patients who have received this device should consult with their surgeon if they have any concerns. Healthcare providers should review their inventory and contact Medacta Usa Inc for further information on recalls and device management.
The recalled product
- Product
- MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
- Manufacturer
- Medacta Usa Inc
- Affected units
- 53
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 07630345732293
- 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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Same hazard · screw breakage
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