Device product
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Z-1186-2021
Product summary
- Event
- Event 87350
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 devices
- Official record key
device-enforcement:Z-1186-2021
Official wording
Reason: Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
Code information: Catalogue # 5536-B-400, Lot Number CTD44301
Distribution pattern: Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.
Derived failure modes
-
Unknown
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.