Recall Z-1405-2023
Medacta Usa Inc · initiated March 8, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Codes / lots: UDI/DI 07630345732330, All Lot Numbers
Reason for recall
There is a potential for breakage of the small screw used to affix the anti-backout plate.
FDA-determined 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.
Details
- Recall number
- Z-1405-2023
- Initiated
- March 8, 2023
- Posted by FDA
- April 19, 2023
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Quantity
- 50 units
- Distribution
- US: ID, TX, GA, VA, AZ
- Recalling firm
- Medacta Usa Inc, Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1400-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | 03/08/2023Completed |
| Z-1401-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | 03/08/2023Completed |
| Z-1402-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | 03/08/2023Completed |
| Z-1403-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | 03/08/2023Completed |
| Z-1404-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | 03/08/2023Completed |