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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

DePuy Spine, Inc.: 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

Agency Publication Date: July 1, 2022
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Affected Products

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

UDI-DI: 04260557770658 Lot Number: E20CL0603

Lot Numbers:
Number
Product: 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

UDI-DI: 04260557770573 Lot Number: E20CL0637

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90390
Status: Active
Manufacturer: DePuy Spine, Inc.
Manufactured In: United States
Units Affected: 2 products (61 units; 46 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.