Home / Recalls / Instrumed International, Inc. / Z-0543-2015

Z-0543-2015 Class II Terminated

Recalled by Instrumed International, Inc. — Schaumburg, IL

FDA device recall Z-0543-2015 was initiated by Instrumed International, Inc. on September 8, 2014 and is designated Class II. Reason for recall: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements … The recall status is terminated (terminated November 29, 2017). Affected quantity: 4 Cushing burrs.

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
September 8, 2014
Termination Date
November 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 Cushing burrs

Product 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.

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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

Distribution Pattern

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Code Information

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.

Other recalls by Instrumed International, Inc.

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  • Z-0532-2015 Class II — A uterine tenaculum is a hook-like instrument used to seize and hold the cervix (September 8, 2014)
  • Z-0550-2015 Class II — Gardner-Wells traction tongs are skull tongs for traction used to immobilize a p (September 8, 2014)
  • Z-0557-2015 Class II — Cloward Spanner gauges are bone cutting and drilling instruments that are used w (September 8, 2014)
  • Z-0533-2015 Class II — An endometrial suction curette is a device used to remove material from the uter (September 8, 2014)
  • Z-0555-2015 Class II — Gardner-Wells wrenches are used in traction skull tongs for traction used to imm (September 8, 2014)
  • Z-0559-2015 Class II — Schoitz weights are manual devices used with Schoitz tonometers and are intended (September 8, 2014)
  • Z-0544-2015 Class II — Hudson burrs are bone cutting and drilling instruments that are used without a p (September 8, 2014)
  • Z-0534-2015 Class II — A zipser clamp is an instrument used to compress reduce blood flow to the penis (September 8, 2014)
  • Z-0538-2015 Class II — A circumcision clamp is an instrument used to compress the foreskin of the penis (September 8, 2014)

FDA data resources