Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2015 - (Recall #: Z-2389-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 29, 2015

Date Posted: August 26, 2015

Recall Number: Z-2389-2015

Event ID: 71678

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).

Status: Terminated

Product Quantity: 10 units

Code Information:

Catalog number 5530-G-209 Lot Code LEF064

Distribution Pattern:

OH, SC, RI, WV

Voluntary or Mandated:

Voluntary: Firm initiated