EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
This recall is currently active, issued October 21, 2022.
- Recall Initiated
- August 12, 2022
- Posted
- October 21, 2022
- Recall Number
- Z-0125-2023
- Quantity
- 4
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
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
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Lot / Code Info
UDI-DI/Lot: 00190446309833/629Z1085
Root Cause
Process control
Action Taken
On 8/12/22, recall notices were emailed to DJO Surgical Agents who were informed to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected devices have been transferred. 2) Return affected devices 3) Complete and return the response form Questions, contact: Julie.Baker@Enovis.com