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
- Hazard
- screw-breakage
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:
- AZ
- GA
- ID
- TX
- VA
Related recalls
Same category
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- SevereDexcom G7 Continuous Glucose Monitoring System sensors recalled
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01