FDA Recall
Terminated
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Recall: Z-0711-2017
·
Initiated November 15, 2016
Recall
- Recall Number
- Z-0711-2017
- Event Number
- 75715
- FEI Number
- 1000116912
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- November 15, 2016
- Terminated
- January 20, 2017
- Address
- 9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445
Description
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Reason
A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
Action
The recalling firm sent an Urgent Field Safety Notice letter dated November 15, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 760-734-3551.
Distribution
US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
Quantity
7 units