Recall Z-1401-2023— Medacta Usa Inc

Name: FDA recall Z-1401-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-08

Class II · Completed

Class II FDA medical device recall by Medacta Usa Inc, initiated 2023-03-08. It names one FDA 510(k) clearance: K221545. Product: MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device. Reason: There is a potential for breakage of the small screw used to affix the anti-backout plate..

Recalling firm: Medacta Usa Inc
Classification: Class II
Status: Completed
Initiated: 2023-03-08
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K221545 — MectaLIF Anterior ExtensionMedacta International S.A.·cleared 2022-10-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

There is a potential for breakage of the small screw used to affix the anti-backout plate.

Data sourced from openFDA. This site is unofficial and independent of the FDA.