Z-0125-2023 Class II Ongoing
FDA device recall Z-0125-2023 was initiated by Encore Medical, LP on Aug 12, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 2, 2022
- Initiation Date
- Aug 12, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0125-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026