Severity
Moderate
FDA Devices recall · Reported July 13, 2022
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 …
DePuy Spine, Inc. recalled EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use … - a moderate-severity action.
EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use … was recalled by DePuy Spine, Inc. in July 13, 2022. Reason: Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and P…. Check the official notice for the remedy. Verify recall #Z-1324-2022 with the FDA Devices before acting.
The recall
DePuy Spine, Inc. issued this moderate-severity FDA Devices recall-Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and P….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1324-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1324-2022) was formally reported on July 13, 2022, with the manufacturer initiating the action on May 20, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. DePuy Spine, Inc. is listed as the recalling firm, operating out of Raynham, MA. Federal records list the affected scope as 46 units.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Distribution US Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
46 units
Related Recalls
6
3 from same agency
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
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
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1324-2022 |
| Date reported | July 13, 2022 |
| Date initiated | May 20, 2022 |
| Recalling firm | DePuy Spine, Inc. |
| Firm location | Raynham, MA |
| Affected scope | 46 units |
| Distribution | Distribution US Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 13, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.