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Recall Observatory FDA recall evidence

Device product

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

Z-0328-2018

December 12, 2017

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 78727
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0328-2018

Official wording

Reason: 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.

Code information: Lot 252564

Distribution pattern: One medical device distributor in California.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.