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Recall Observatory FDA recall evidence

Device product

EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.

Z-0125-2023

August 12, 2022

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 90882
Status
Ongoing
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-0125-2023

Official wording

Reason: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.

Code information: UDI-DI/Lot: 00190446309833/629Z1085

Distribution pattern: US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.