Z-1401-2023Class II

MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

Name: Z-1401-2023 MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
Creator: Medacta Usa Inc
Published: 2023-03-08
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2023-03-08 / Completed

FDA source

Medacta Usa Inc began a recall of MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device on 2023-03-08. FDA classified it as Class II and gives the reason as "There is a potential for breakage of the small screw used to affix the anti-backout plate". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-1401-2023
Classification: Class II
Status: Completed
Initiated: 2023-03-08
Posted: 2023-04-19
Recalling firm: Medacta USA, Inc.
Product: MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: There is a potential for breakage of the small screw used to affix the anti-backout plate.
FDA 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 in commerce: 53 units
Distribution: US: ID, TX, GA, VA, AZ
Product codes and lots: UDI/DI 07630345732293, All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1401-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1400-2023	Class II	Completed	Voluntary: Firm initiated	2023-04-26	2023-04-19
Z-1401-2023	Class II	Completed	Voluntary: Firm initiated	2023-04-26	2023-04-19
Z-1402-2023	Class II	Completed	Voluntary: Firm initiated	2023-04-26	2023-04-19
Z-1403-2023	Class II	Completed	Voluntary: Firm initiated	2023-04-26	2023-04-19
Z-1404-2023	Class II	Completed	Voluntary: Firm initiated	2023-04-26	2023-04-19
Z-1405-2023	Class II	Completed	Voluntary: Firm initiated	2023-04-26	2023-04-19

Product code OVD

K221545Class IIMectaLIF Anterior ExtensionMedacta International S.A. / cleared 2022-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)