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Recall Observatory FDA recall evidence

Device product

MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device

Z-1405-2023

March 08, 2023

Class II

Product summary

Firm
Medacta Usa Inc
Event
Event 91947
Status
Completed
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-1405-2023

Official wording

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

Code information: UDI/DI 07630345732330, All Lot Numbers

Distribution pattern: US: ID, TX, GA, VA, AZ

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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