Z-1323-2022 Class II Ongoing
FDA device recall Z-1323-2022 was initiated by DePuy Spine, Inc. on May 20, 2022 and is designated Class II. Reason for recall: Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton The recall status is ongoing. Affected quantity: 61 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2022
- Initiation Date
- May 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
Product Description
EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L
Reason for Recall
Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
Distribution Pattern
Distribution US Nationwide
Code Information
UDI-DI: 04260557770658 Lot Number: E20CL0603