Device product
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.
Z-0041-2018
Product summary
- Event
- Event 78193
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 units
- Official record key
device-enforcement:Z-0041-2018
Official wording
Reason: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Code information: Lot Number 287U1004
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.