🔍 RecallPedia

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 I - Dangerous
🏥 Medical Devices Recalled: September 8, 2014 Instrumed International Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Instrumed International, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0539-2015

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