FDAFDA · Food and drugs·Recall number Z-0543-2015
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.
Published December 17, 2014 · Recall initiated: September 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumed International, Inc.
- Distributor
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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