Z-0125-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2022
- Initiation Date
- August 12, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
Product Description
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Code Information
UDI-DI/Lot: 00190446309833/629Z1085