EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Recall
- Recall Number
- Z-0042-2018
- Event Number
- 78193
- FEI Number
- 1000116912
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- September 15, 2017
- Terminated
- August 29, 2023
- Address
- 9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445
Description
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
The firm initiated the recall by email on 09/05/2017. The letter identified the affected product, problem and actions to be taken. The consignee was directed to notify anyone to whom the product was transferred and to return any in-stock product.
US Nationwide Distribution
46 units