Recall Z-1961-2012— Stryker Endoscopy

Name: FDA recall Z-1961-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-19

Class II · Terminated

Class II FDA medical device recall by Stryker Endoscopy, initiated 2012-06-19, terminated 2012-10-23. It names one FDA 510(k) clearance: K935237. Product: Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.. Reason: The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's evaluation that identified original validation was not done at worst case conditions..

Recalling firm: Stryker Endoscopy
Classification: Class II
Status: Terminated
Initiated: 2012-06-19
Terminated: 2012-10-23
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K935237 — STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIESStryker Endoscopy·cleared 1994-03-21

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 brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.

Reason for recall

The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's evaluation that identified original validation was not done at worst case conditions.

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