Encore Medical, Lp: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.

Agency Publication Date: October 20, 2017

Affected Products

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 cond

Lot Number 287U1004

Lot Numbers:

Number

Product: EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, 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.

Lot Number 055U1003

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78193

Status: Resolved

Manufacturer: Encore Medical, Lp

Manufactured In: United States

Units Affected: 2 products (48 units; 46 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Number 287U1004

Lot Numbers:

Number

Lot Number 055U1003

Lot Numbers:

Number