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U.S. Department of Health and Human Services

Class 2 Device Recall 45cm Laparoscopic Instruments Sterilization tray

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 Class 2 Recall
45cm Laparoscopic Instruments Sterilization tray
see related information
Date Posted June 22, 2011
Recall Status1 Terminated on October 25, 2011
Recall Number Z-2612-2011
Recall Event ID 59072
Premarket Notification
510(K) Number
K960738 
Product Classification Sterilization Wrap Containers, Trays, Cassettes & Other Accessories - Product Code KCT
Product 45cm Laparoscopic Instruments Sterilization tray. Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138 Designed to hold laparoscopic surgical manual instruments which are intended for cutting, holding, grasping and manipulating tissue, organs, organ area, surgical auxiliaries such as suturing material. The 45cm Lap tray can hold up to 11 instruments in the top tier and a combination of instruments in the bottom tier provided that the total weight of the loaded tray does not exceed 6.53 kg.
Code Information Model number 250-015-704. All serial/lot numbers.
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138-1400
For Additional Information Contact Michael Hillendoerfer
408-754-2664
Manufacturer Reason
for Recall
During testing and review, Stryker Endoscopy discovered that the sterilization parameters for the 132 degree C gravity steam sterilization cycle in the IFU may not consistently sterilize all instruments in the 45cm Laparoscopic Instruments Tray.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Stryker Endoscopy sent a "URGENT: DEVICE CORRECTION" letter dated June 8, 2011 to affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to discard all old Instructions for Use sheets for their 45cm Laparoscopic Tray and download the new IFU from the URL link:http://stryker.com/45cm tray. Additionally, customers were instructed to complete and return an attached "acknowledgement of receipt" form and fax to 408-754-8378 or scan and e-mail to trays@stryker.com. Questions can be answered by calling 1-800-624-4422 or by e-mail at trays@stryker.com.
Quantity in Commerce 603
Distribution Worldwide Distribution--USA (nationwide) and countries of Brazil, Canada, Chili, Germany , Korea, Mexico, Philippines, Poland, Portugal, Singapore, Sweden, Switzerland, and Taiwan.
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 = KCT and Original Applicant = ENGINEERED CUSTOM MFG., INC.
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