PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 2, 2014 Initiated: May 19, 2014 #Z-1872-2014

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Stryker Endoscopy
Units Affected
1992 trays
Distribution
Worldwide Distribution.
Location
San Jose, CA

Frequently Asked Questions

What product was recalled?
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.. Recalled by Stryker Endoscopy. Units affected: 1992 trays.
Why was this product recalled?
STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 2, 2014. Severity: Moderate. Recall number: Z-1872-2014.