Home / Recalls / Instrumed International, Inc. / Z-0542-2015

Z-0542-2015 Class II Terminated

Recalled by Instrumed International, Inc. — Schaumburg, IL

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
9 perforating drills

Product Description

Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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 Perforating, Drill, 3/8", 10 mm; Instrumed Product Number: 600-00509; Trade Name: Boss Industries; Boss Industries Product Name: Cushing Perforating, Drill, 3/8", 10 mm; Boss Industries Item Number: 74-0100; Lot Number: 110211. 2) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Symmetry Surgical Item Number: 57-6034; Lot Number: 060212. 3) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: Medfix International; Medfix International Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Medfix International Item Number: MF223-1577; Lot Number: 060212. 4) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Stealth Surgical Item Number: SS2122; Lot Number: 060212. 5) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: CareFusion; CareFusion Product Name: Cushing Perforating, Drill, 1/2", 13 mm; CareFusion Item Number: VM85-1213; Lot Number: 060212, 110313.

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