Device product
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Z-0953-2013
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 64465
- Status
- Terminated
- Classification
- Class II
- Quantity
- 123 devices
- Official record key
device-enforcement:Z-0953-2013
Official wording
Reason: A dimensional mismatch was identified which can potentially allow for interference between devices.
Code information: Catalog # 02-012-42-3508 All lot numbers
Distribution pattern: 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.
Derived failure modes
-
Unknown
A dimensional mismatch was identified which can potentially allow for interference between devices.