Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee Syst…

Recall date

May 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2389-2015

FDA classification

Class II

Brand / firm

Stryker Howmedica Osteonics Corp.

Sold / distributed

OH, SC, RI, WV

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.