MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
FDA device recall Z-1403-2023 · posted 2023-04-19 · Completed
Recall details
- Recalling firm
- Medacta Usa Inc
- Reason for recall
- There is a potential for breakage of the small screw used to affix the anti-backout plate.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Completed
- Product code
- OVD
- Quantity affected
- 34 units
- Distribution
- US: ID, TX, GA, VA, AZ
- Date initiated
- 2023-03-08
- Date posted
- 2023-04-19
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MectaLIF Anterior Extension (K221545) | Medacta International S.A. | 2022-10-24 |