FDA recall Z-0041-2018

Encore Medical, Lp · Class II · 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.

Reason for recall

It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2017-09-15
Report date
2017-11-01
Termination date
2023-08-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0041-2018