FDA-Device2015-05-27Class II
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
Stryker Howmedica Osteonics Corp.
Hazard
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.
Sold states
Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.
Affected count
1,147 in total
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1635-2015Don't want to check this manually?
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