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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 62346
Product Type Devices
Status Ongoing
Recalling Firm Stryker Endoscopy
City San Jose
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution--USA (nationwide)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. All serial/lot numbers Class II 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. 6388 units Z-1961-2012