FDA-Device2018-01-17Class II
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
Encore Medical, Lp
Hazard
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.
Sold states
One medical device distributor in California.
Affected count
2 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0329-2018Don't want to check this manually?
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