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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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 Class 2 Recall
Stryker
see related information
Date Posted July 09, 2012
Recall Status1 Terminated on October 23, 2012
Recall Number Z-1961-2012
Recall Event ID 62346
Premarket Notification
510(K) Number
K935237 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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.
Code Information All serial/lot numbers
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138-1400
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Michael Hilldoerfer
408-754-2124
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Stryker Endoscopy sent a Urgent Device Correction letter dated June 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to: 1. Discard any old Instructions for Use for your Arthroscope and Hardware Set Tray. 2. Download the new IFU from the URL link: http://stryker.com/arthrotray . Complete and sign the enclosed acknowledgement of receipt form and fax to (408) 754-8378 or scan in and email to trays@stryker.com.* It is important to send the self addressed confirmation form back to Stryker. Stryker is committed to delivering the highest quality products to its customers. We sincerely apologize for any inconvenience this action may cause. If you have any questions regarding this letter please contact us at 1-800-624-4422 or via email at trays@stryker.com. .
Quantity in Commerce 6388 units
Distribution Worldwide Distribution--USA (nationwide)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Stryker Endoscopy
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