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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

restor3d Inc.: Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.; During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Agency Publication Date: April 29, 2022
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Affected Products

Product: Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument

Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506

Lot Numbers:
2022030005
Product: Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument

Model: 6101-20181018; Lot: 2022010031; UDI: 00840097501574

Lot Numbers:
2022010031
Product: Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598

Lot Numbers:
2022010035

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89983
Status: Resolved
Manufacturer: restor3d Inc.
Manufactured In: United States
Units Affected: 3 products (14 units; 4 units; 9 units)
Agency Last Updated: May 2, 2022

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.