PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 1, 2017 Initiated: September 15, 2017 #Z-0041-2018

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.

Details

Recalling Firm
Encore Medical, Lp
Units Affected
48 units
Distribution
US Nationwide Distribution
Location
Austin, TX

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Encore Medical, Lp. Units affected: 48 units.
Why was this product recalled? ▼
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2017. Severity: Moderate. Recall number: Z-0041-2018.

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