Device product
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Z-2329-2021
Product summary
- Event
- Event 88422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 US; 2 OUS
- Official record key
device-enforcement:Z-2329-2021
Official wording
Reason: The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.
Code information: Lot JHS2H
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.
Derived failure modes
-
Unknown
The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.