Device product
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Z-0726-2023
Product summary
- Firm
- Corin Ltd
- Event
- Event 91183
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0726-2023
Official wording
Reason: The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Code information: UDI/DI (01) 0 5055196 96833 2, Lot 503150
Distribution pattern: US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
Derived failure modes
-
Unknown
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.