Recall Z-1872-2014— Stryker Endoscopy

Name: FDA recall Z-1872-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-19

Class II · Terminated

Class II FDA medical device recall by Stryker Endoscopy, initiated 2014-05-19, terminated 2015-05-07. It names one FDA 510(k) clearance: K941333. Product: Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.. Reason: STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing..

Recalling firm: Stryker Endoscopy
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Terminated: 2015-05-07
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K941333 — SE5 ARTHROSCOPY SYTEMStryker Endoscopy·cleared 1994-11-10

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

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.

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