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Devices
Device Recall Proximal Tibial Spacer
Model / Serial
Catalog # 02-012-42-3508 All lot numbers
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
Product Description
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Manufacturer
Exactech, Inc.
1 Event
Recall of Device Recall Proximal Tibial Spacer
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Manufacturer
Exactech, Inc.
Manufacturer Address
Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
Manufacturer Parent Company (2017)
Exactech Inc
Source
USFDA
Language
English
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