PlainRecalls
FDA Devices Moderate Class II Ongoing

EIT CIF cage, H 7mm, 8degree, S- 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: CUI8070S

Reported: July 13, 2022 Initiated: May 20, 2022 #Z-1324-2022

Product Description

EIT CIF cage, H 7mm, 8degree, S- 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: CUI8070S

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

Details

Recalling Firm
DePuy Spine, Inc.
Units Affected
46 units
Distribution
Distribution US Nationwide
Location
Raynham, MA

Frequently Asked Questions

What product was recalled?
EIT CIF cage, H 7mm, 8degree, S- 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: CUI8070S. Recalled by DePuy Spine, Inc.. Units affected: 46 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1324-2022.