Device product
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Z-2284-2013
Product summary
- Event
- Event 66355
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60
- Official record key
device-enforcement:Z-2284-2013
Official wording
Reason: One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Code information: REF: 1150000 Lot: 0207029284
Distribution pattern: Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
Derived failure modes
-
Unknown
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.