FDA recall Z-0328-2018

Encore Medical, Lp · Class II · device

Product

EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.

Reason for recall

The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.

Distribution

One medical device distributor in California.

Key facts

Status
Terminated
Initiation date
2017-12-12
Report date
2018-01-17
Termination date
2022-06-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0328-2018