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.
Enforcement
- Recall Number
- Z-0543-2015
- Event ID
- 69471
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Instrumed International, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 17, 2014
- Initiation Date
- September 8, 2014
- Classification Date
- December 8, 2014
- Termination Date
- November 29, 2017
- Address
- 626 Cooper Ct, N/A, Schaumburg, IL, 60173-4537, United States
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.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
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.
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
4 Cushing burrs