FDA-Device2015-08-26Class II
Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
Stryker Howmedica Osteonics Corp.
Hazard
Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).
Sold states
OH, SC, RI, WV
Affected count
10 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2389-2015Don't want to check this manually?
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