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Devices
Device Recall Foundation Total Knee System.
Model / Serial
Lot #426142 and #426132.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.
Product Description
Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
Manufacturer
Encore Medical, Lp
1 Event
Recall of Device Recall Foundation Total Knee System.
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Manufacturer
Encore Medical, Lp
Manufacturer Address
Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
Source
USFDA
Language
English
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