Recall Z-2389-2015— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2389-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-29

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2015-05-29, terminated 2016-09-26. It names one FDA 510(k) clearance: K141056. Product: 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.. Reason: 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)..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Terminated: 2016-09-26
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K141056 — TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTSStryker Orthopaedics·cleared 2014-08-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.