Recall Z-1405-2023 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medacta Usa Inc
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
| Date | Apr 19, 2023 (initiated Mar 8, 2023) |
| Status | Completed |
| Reason | There is a potential for breakage of the small screw used to affix the anti-backout plate. |
| Root cause | Under Investigation by firm |
| Action | Medacta USA initially notified its direct consignees by telephone on 03/08/2023 and followed with an URGENT - Field Safety Notice sent by email on 03/22/2023. The notice explained the issue and requested the units be returned and the notice be sent forward to all people and organizations potentially affected. |
| Quantity | 50 units |
| Distribution | US: ID, TX, GA, VA, AZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221545 | MectaLIF Anterior Extension Medacta International S.A., Oct 24, 2022 |