Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1) Instrumed Product Name: Cushing Burr, 3/8", 10 mm; Instrumed Product Number: 600-00529; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 3/8", 10 mm; Medfix International Item Number: MF223-1592; Lot Number: 060311. 2) Instrumed Product Name: Cushing Burr, 5/8", 16 mm; Instrumed Product Number: 600-00534; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 5/8", 16 mm; Medfix International Item Number: MF223-1597; Lot Number: 060311. 3) Instrumed Product Name: Cushing Burr, 3/4", 20 mm; Instrumed Product Number: 600-00539; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Burr, 3/4", 20 mm; Stealth Surgical Item Number: SS2133; Lot Number: 060311.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Instrumed International, Inc.
- Reason for Recall:
- The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
Product Codes/Lot Numbers:
1) Instrumed Product Name: Cushing Burr, 3/8", 10 mm; Instrumed Product Number: 600-00529; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 3/8", 10 mm; Medfix International Item Number: MF223-1592; Lot Number: 060311. 2) Instrumed Product Name: Cushing Burr, 5/8", 16 mm; Instrumed Product Number: 600-00534; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 5/8", 16 mm; Medfix International Item Number: MF223-1597; Lot Number: 060311. 3) Instrumed Product Name: Cushing Burr, 3/4", 20 mm; Instrumed Product Number: 600-00539; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Burr, 3/4", 20 mm; Stealth Surgical Item Number: SS2133; Lot Number: 060311.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0543-2015
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