FDA-Device2014-12-17Class II
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.
Instrumed International, Inc.
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Sold states
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Affected count
790 distractor screws
Manufactured in
626 Cooper Ct, N/A, Schaumburg, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0556-2015Don't want to check this manually?
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