Device product
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Z-2009-2023
Product summary
- Event
- Event 92459
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-2009-2023
Official wording
Reason: Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Code information: UDI-DI: 08033390244824; All Lots
Distribution pattern: US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Derived failure modes
-
Potency or specification failure
out of specification