RegWardenFDA facility compliance records
Recall

Class II — DePuy Spine, Inc.

Recalling firmDePuy Spine, Inc.
Registered facilityDEPUY SPINE, INC. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonLabel 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
ProductEIT 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
Quantity46 units
DistributionDistribution US Nationwide
Initiated2022-05-20
Classified2022-07-01
Recall numberZ-1324-2022
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — DePuy Spine, Inc. (Z-1324-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90390/

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