PlainRecalls
ModerateClass IIOngoing

FDA Devices recall · Reported July 13, 2022

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

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 …

Recall #
Z-1323-2022
Affected scope
61 units
Initiated
May 20, 2022
Compiled from official public sources by the editorial team.
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DePuy Spine, Inc. recalled EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use … - a moderate-severity action.

EIT CIF cage, H 6mm, 8degree, L- 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-1323-2022 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….

Moderate
severity level
61 units
affected scope
Class II
classification
July 13, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1323-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1323-2022) 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 61 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, 6 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.

Medical Devices recalls over time

Where this recall sits in its category — 40,409 medical devices recalls on record

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,243

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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

61 units

Related Recalls

6

6 from same agency

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-1323-2022
Date reported July 13, 2022
Date initiated May 20, 2022
Recalling firm DePuy Spine, Inc.
Firm location Raynham, MA
Affected scope 61 units
Distribution Distribution US Nationwide

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

61 units units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1323-2022) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting — recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

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.

Frequently Asked Questions

What product was recalled?
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. Recalled by DePuy Spine, Inc.. Units affected: 61 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-1323-2022.
Where was the recalled product distributed?
Distribution: Distribution US Nationwide.
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-1323-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 13, 2022.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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 June 2026.