FDA-Device2021-03-17Class II
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Howmedica Osteonics Corp.
Hazard
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
Sold states
Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.
Affected count
11 devices
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1186-2021Don't want to check this manually?
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