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Recall Observatory FDA recall evidence

Device product

Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

Z-2661-2017

May 19, 2017

Class II

Product summary

Firm
Medacta Usa Inc
Event
Event 77467
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-2661-2017

Official wording

Reason: One lot of product does not include a screw for attachment to the tibial base plate.

Code information: Lot # 163646

Distribution pattern: CA, AZ, NC, Israel, France

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot of product does not include a screw for attachment to the tibial base plate.