MectaLIF Anterior recallZ-1402-2023 · Medacta Usa Inc · initiated Mar 8, 2023
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medacta Usa Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential for breakage of the small screw used to affix the anti-backout plate.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1402-2023
- Status
- Completed
- Initiated by the company
- Mar 8, 2023
- Posted by the FDA
- Apr 19, 2023
- Recalling firm
- Medacta Usa Inc
- Quantity
- 44 units
- Product code
- OVD
- FDA submissions
- K221545
- Distribution
- US: ID, TX, GA, VA, AZ
Product description
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
Code information (models, lots, serial numbers)
UDI/DI 07630345732309, All Lot Numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MectaLIF Anterior 03.30.302Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 91947).
- Z-1400-2023 · CompletedMectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
- Z-1401-2023 · CompletedMectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
- Z-1403-2023 · CompletedMectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
- Z-1404-2023 · CompletedMectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
- Z-1405-2023 · CompletedMectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page