Instrumed International, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0539-2015)

Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.

Class II

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Millennium Surgical Item Number: 0-48239; Lot Numbers: 020212, 120312. 2) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Symmetry Surgical Item Number: 57-6305; Lot Numbers: 020212, 100111, 100213, 120312. 3) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Medline Industries Item Number: MDG1806301; Lot Numbers: 020212, 100111. 4) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: CareFusion; CareFusion Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; CareFusion Item Number: VM85-1261; Lot Number: 100111. 5) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312. 6) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312. 7) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Instrumed Product Number: 590-06496; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Millennium Surgical Item Number: 0-48240; Lot Numbers: 010312, 090113, 120312. 8) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Instrumed Product Number: 590-06496; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Symmetry Surgical Item Number: 57-6306; Lot Numbers: 010312, 090113, 120312. 9) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Instrumed Product Number: 590-06496; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Medline Industries Item Number: MDG1806306; Lot Number: 010312. 10) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Instrumed Product Number: 590-06496; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Boss Instruments Item Number: 74-0152; Lot Numbers: 010312, 120312. 11) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Millennium Surgical Item Number: 74-0152; Lot Numbers: 060213, 090411, 110412, 120312. 12) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Symmetry Surgical Item Number: 57-6309; Lot Numbers: 060213, 090411, 110412, 120312. 13) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Medline Industries Item Number: MDG1884299; Lot Numbers: 090411. 14) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Surgical Direct; Surgical Direct Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Surgical Direct Item Number: SD145691.102; Lot Numbers: 060213, 120312. 15) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: CareFusion; CareFusion Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; CareFusion Item Number: VM85-1265; Lot Number: 090411. 16) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Boss Instruments Item Number: 74-0154; Lot Numbers: 060213, 090411, 110412, 120312. 17) Instrumed Product Name: Michele Trephine 10", customer over all length, 4.8 mm OD; Instrumed Product Number: 590-06506; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine 10", customer over all length, 4.8 mm OD; Boss Instruments Item Number: 74-0155; Lot Number: 090411. 18) Instrumed Product Name: Michele Trephine 10", customer over all length, 5.5 mm OD; Instrumed Product Number: 590-06506; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine 10", customer over all length, 5.5 mm OD; Boss Instruments Item Number: 74-0156; Lot Number: 020213, 030111.

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

Voluntary: Firm initiated