MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
- Company
- Medacta Usa Inc
- Recall Initiated
- March 8, 2023
- Posted
- April 19, 2023
- Recall Number
- Z-1404-2023
- Quantity
- 17 unis
- Firm Location
- Memphis, TN
Reason for Recall
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Distribution
US: ID, TX, GA, VA, AZ
Lot / Code Info
UDI/DI 07630345732323, All Lot Numbers
Root Cause
Under Investigation by firm
Action Taken
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.