Z-0726-2023 Class II Ongoing
FDA device recall Z-0726-2023 was initiated by Corin Ltd on November 8, 2022 and is designated Class II. Reason for recall: The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2022
- Initiation Date
- November 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Reason for Recall
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Distribution Pattern
US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
Code Information
UDI/DI (01) 0 5055196 96833 2, Lot 503150