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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

Straumann Manufacturing, Inc.: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration

Agency Publication Date: August 12, 2016
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Affected Products

Product: Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510

Lot Numbers: LR810; LT122

Lot Numbers:
Numbers
Product: Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512

Lot Number: LT123

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 74799
Status: Resolved
Manufacturer: Straumann Manufacturing, Inc.
Manufactured In: United States
Units Affected: 2 products (70 pieces; 33 pieces)

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.