FDA-Device2014-07-02Class II

Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

Stryker Endoscopy
Hazard

STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.

Sold states
Worldwide Distribution.
Affected count
1992 trays
Manufactured in
5900 Optical Ct, N/A, San Jose, CA, United States
Products
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1872-2014

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