Device product
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
Z-0964-2013
Product summary
- Event
- Event 64456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units (total of 2 sets)
- Official record key
device-enforcement:Z-0964-2013
Official wording
Reason: The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
Code information: Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right). Lot Codes: AP5W52 and AP7H19.
Distribution pattern: 1 Branch (NJ) with one consignee (DE).
Derived failure modes
-
Unknown
The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.