Z-0041-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2017
- Initiation Date
- September 15, 2017
- Termination Date
- August 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 units
Product Description
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, 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.
Reason for Recall
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Number 287U1004