Is Alpen Clinic 100 Carbide Instruments (R100057C) recalled?

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. Status: Voluntary: Firm initiated Initial Firm Notification: E-Mail Distribution: Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.

Medium RiskFDA Device

Coltene Whaledent Inc: The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

Agency Publication Date: November 17, 2020

Affected Products

Product: Alpen Clinic 100 Carbide Instruments (R100057C)

J75023

Product: FG 57 100057X (100057X)

J79552

Product: Clinic Pack 100 Pieces FG 57 100057C (100057C)

J74027

Product: CEI Cutting Edge Instruments (PTC-57C)

J88954

Product: Strauss 25 Carbide Dental Burs (100057XXV)

J77147 J93636

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86694

Status: Active

Manufacturer: Coltene Whaledent Inc

Manufactured In: United States

Units Affected: 5 products (556 packs; 556; 556; 556; 556)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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.