FDAFDA · Food and drugs·Recall number Z-0041-2018
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.
Published November 1, 2017 · Recall initiated: September 15, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- US Nationwide Distribution
- Lot
- Lot Number 287U1004
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.