FDA-Device2017-11-01Class II
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 cond
Encore Medical, Lp
Hazard
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Sold states
US Nationwide Distribution
Affected count
48 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0041-2018Don't want to check this manually?
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