FDA Medical Device Recalls (openFDA)
Medacta Usa Inc: MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
- Recall number
- Z-1400-2023
- Recalling firm
- Medacta Usa Inc
- Product
- MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
- Status
- Completed
- Initiated
- 2023-03-08
- Posted
- 2023-04-19
- Terminated
- not on file
- 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
- 32 units
- Distribution
- US: ID, TX, GA, VA, AZ
- Lot, serial or model codes
- UDI/DI 07630345732286, All Lot Numbers
- 510(k) numbers
- ["K221545"]
- PMA numbers
- not on file
- Product code
- OVD
- Firm FEI
- 3006639916
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28