Date Initiated by Firm | June 19, 2012 |
Date Posted | July 09, 2012 |
Recall Status1 |
Terminated 3 on October 23, 2012 |
Recall Number | Z-1961-2012 |
Recall Event ID |
62346 |
510(K)Number | K935237 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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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 CA 95138-1400
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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 | 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.
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Quantity in Commerce | 6388 units |
Distribution | Worldwide Distribution--USA (nationwide) |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GEI
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