Recall Z-1323-2022— DePuy Spine, Inc.

Name: FDA recall Z-1323-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-20

Class II · Ongoing

Class II FDA medical device recall by DePuy Spine, Inc., initiated 2022-05-20. It names one FDA 510(k) clearance: K170503. 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: 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.

Recalling firm: DePuy Spine, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-05-20
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K170503 — EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF CagesEit Emerging Implant Technologies GmbH·cleared 2017-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.