FDA recall Z-1323-2022

Product

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

Distribution US Nationwide

Key facts

Status

Ongoing

Initiation date

2022-05-20

Report date

2022-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1323-2022