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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

Meta C.G.M. Spa: Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

Agency Publication Date: June 2, 2021
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Affected Products

Product: REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

Lot number: 10-10719, 25-31118, 23-27018, 16-17118, 15-17018, 2-01521, 23-26620, 23-26820, 17-17920, 7-06519, 17-19818, 17-19818, and 13-12818

Lot Numbers:
number
Product: REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.

Lot number: 2-01121, 23-28920, 21-26520, 18-24819, 24-29118, 21-24818, 13-12818, 26-33118

Lot Numbers:
number
Product: REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.

Lot number: 26-33118 and 17-19818

Lot Numbers:
number
Product: REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.

Lot number: 1-35319

Lot Numbers:
number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87866
Status: Resolved
Manufacturer: Meta C.G.M. Spa
Manufactured In: Italy
Units Affected: 4 products (8,370 units; 1,692; 150 units; 27 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.