🔍 RecallPedia

CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical 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: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5106; Lot Number: 090109. 2) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Millennium Surgical Item Number: 57-5106; Lot Number: 090109. 3) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Medfix International Item Number: MF232-9052; Lot Numbers: 050214, 090109, 1290018. 4) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; CareFusion Item Number: VM84-3602; Lot Numbers: 090109. 5) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Boss Instruments; Boss Instruments Product Name: CVB Distraction Screw, pkg 5, 12 mm, Non-Sterile; Boss Instruments Item Number: 73-2591; Lot Numbers: 090109. 6) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5107; Lot Numbers: 020313, 090209. 7) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Millennium Surgical Item Number: 6-2878; Lot Numbers: 070109, 090109, 090209. 8) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medline Industries; Medline Industries Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medline Industries Item Number: MDG1108066; Lot Numbers: 020313, 090209. 9) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medfix International Item Number: MF232-9057; Lot Numbers: 020313, 050214, 090209. 10) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Surgical Direct; Surgical Direct Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Surgical Direct Item Number: SD145691.103; Lot Number: 090209. 11) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; CareFusion Item Number: VM84-3603; Lot Numbers: 020313, 090209. 12) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Distraction Screw CVD 14 mm; Teleflex Medical Item Number: P-22488; Lot Number: 090209. 13) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5108; Lot Numbers: 010114, 120408. 14) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Millennium Surgical Item Number: 6-2879; Lot Number: 120408. 15) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Medfix International Item Number: MF232-9062; Lot Number: 120408. 16) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; CareFusion Item Number: VM84-3604; Lot Number: 120408. 17) Instrumed Product Name: CVB Distraction Screw, 18 mm, Non-Sterile; Instrumed Product Number: 650-11486; Trade Name: Symmetry Surgical; Symmetry SurgicalProduct Name: CVB Distraction Screw, 18 mm, Non-Sterile; Symmetry SurgicalItem Number: 57-5100; Lot Numbers: 040109, 121610.
  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:

CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.

Product Codes/Lot Numbers:

1) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5106; Lot Number: 090109. 2) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Millennium Surgical Item Number: 57-5106; Lot Number: 090109. 3) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Medfix International Item Number: MF232-9052; Lot Numbers: 050214, 090109, 1290018. 4) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; CareFusion Item Number: VM84-3602; Lot Numbers: 090109. 5) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Boss Instruments; Boss Instruments Product Name: CVB Distraction Screw, pkg 5, 12 mm, Non-Sterile; Boss Instruments Item Number: 73-2591; Lot Numbers: 090109. 6) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5107; Lot Numbers: 020313, 090209. 7) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Millennium Surgical Item Number: 6-2878; Lot Numbers: 070109, 090109, 090209. 8) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medline Industries; Medline Industries Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medline Industries Item Number: MDG1108066; Lot Numbers: 020313, 090209. 9) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medfix International Item Number: MF232-9057; Lot Numbers: 020313, 050214, 090209. 10) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Surgical Direct; Surgical Direct Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Surgical Direct Item Number: SD145691.103; Lot Number: 090209. 11) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; CareFusion Item Number: VM84-3603; Lot Numbers: 020313, 090209. 12) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Distraction Screw CVD 14 mm; Teleflex Medical Item Number: P-22488; Lot Number: 090209. 13) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5108; Lot Numbers: 010114, 120408. 14) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Millennium Surgical Item Number: 6-2879; Lot Number: 120408. 15) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Medfix International Item Number: MF232-9062; Lot Number: 120408. 16) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; CareFusion Item Number: VM84-3604; Lot Number: 120408. 17) Instrumed Product Name: CVB Distraction Screw, 18 mm, Non-Sterile; Instrumed Product Number: 650-11486; Trade Name: Symmetry Surgical; Symmetry SurgicalProduct Name: CVB Distraction Screw, 18 mm, Non-Sterile; Symmetry SurgicalItem Number: 57-5100; Lot Numbers: 040109, 121610.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0556-2015

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