Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2015 - (Recall #: Z-2360-2015)

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:

Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.

Product Classification:

Class II

Date Initiated: May 29, 2015

Date Posted: August 19, 2015

Recall Number: Z-2360-2015

Event ID: 71677

Reason for Recall:

Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.

Status: Terminated

Product Quantity: 26 units

Code Information:

Catalog Number 5532-G-511 Lot LD8D7Y Catalog Number 5537-G-319 Lot TT6JT2

Distribution Pattern:

Worldwide Distribution - US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated