FDAFDA · Food and drugs·Recall number Z-0556-2015
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.
Published December 17, 2014 · Recall initiated: September 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumed International, Inc.
- Distributor
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Lot
- 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 D
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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