FDA-Device2014-12-17Class II
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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
8 Hudson braces
Manufactured in
626 Cooper Ct, N/A, Schaumburg, IL, United States
Products
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0540-2015Don't want to check this manually?
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