FDA Recall
Open, Classified
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Recall: Z-0126-2023
·
Initiated August 12, 2022
Recall
- Recall Number
- Z-0126-2023
- Event Number
- 90882
- FEI Number
- 1000116912
- Product Code
- LPH
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- August 12, 2022
- Posted
- October 21, 2022
- Address
- 9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445
Description
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
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.
Action
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: [email protected]
Distribution
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Quantity
18