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Completed

MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

FDA Recall Z-1404-2023 · Posted 2023-04-19

Recalling FirmMedacta Usa Inc
Recall StatusCompleted
Product CodeOVD
Date Initiated2023-03-08
Product Quantity17 unis

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US: ID, TX, GA, VA, AZ

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K221545MectaLIF Anterior ExtensionMedacta International S.A. · 2022-10-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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