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.
FDA Recall Z-2389-2015 · Posted 2015-08-14
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMBH
Date Initiated2015-05-29
Date Terminated2016-09-26
Product Quantity10 units
Reason for Recall
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).
Firm Action
Stryker Orthopaedics sent a recall notification via email on 5/29/2015 to their local branches. Notification letters and Product Accountability Forms were sent to Stryker branches/agencies with return receipts on 7/2/2015.
Root Cause
Labeling mix-ups
Distribution Pattern
OH, SC, RI, WV
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.