EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Recall
- Recall Number
- Z-0761-2025
- Event Number
- 95882
- FEI Number
- 1000116912
- Product Code
- JWH
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- December 10, 2024
- Posted
- December 23, 2024
- Address
- 9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445
Description
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
On 12/10/2024, recall notices were emailed to customers asking them to do the following: 1. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 2. Review your stock for the products and lot numbers for the items to be returned. 3. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. 4. Complete and return the acknowledgement and response form via email to [email protected] If you have questions contact the firm at [email protected]
US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
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