Spinal fusion device antibackout screw may break, FDA recalls
Medacta Usa Inc is recalling MectaLIF ANTERIOR antibackout lag covers due to potential breakage of the small screw that affixes the anti-backout plate. The defect affects spinal fusion procedures in select 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: This is a risk-of-harm medical device (spinal fusion component) with potential mechanical failure (screw breakage). No injuries or failures have been reported in the source. The theoretical nature of the hazard combined with FDA Class II classification supports a High severity rating.
Plain-English summary
Medacta Usa Inc is recalling the MectaLIF ANTERIOR Antibackout Lag Cover (REF 03.30.305), an interbody fusion device component used in spinal surgery. Fifty units were distributed across five US states: Idaho, Texas, Georgia, Virginia, and Arizona. All lot numbers are included in the recall.
The recall addresses a potential for breakage of the small screw used to affix the anti-backout plate. The FDA has classified this as a Class II recall. The affected devices can be identified using UDI/DI 07630345732330.
The recalled product
- Product
- MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
- Manufacturer
- Medacta Usa Inc
- Hazard
- Affected units
- 50
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 07630345732330
- 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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