FDA-Device2017-11-29Class II
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
Exactech, Inc.
Hazard
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Sold states
Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.
Affected count
333 devices
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0143-2018Don't want to check this manually?
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