Recall Z-1635-2015— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-1635-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-15

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2014-08-15, terminated 2018-01-05. It names 2 FDA 510(k) clearances: K070095, K042993. Product: Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint. Reason: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-08-15
Terminated: 2018-01-05
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K070095 — TRIATHLON TS KNEE SYSTEMHowmedica Osteonics Corp.·cleared 2007-06-01
K042993 — TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENTHowmedica Osteonics Corp.·cleared 2005-01-12

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 femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint

Reason for recall

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

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