—#101010

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.

FDA product code: KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K960738
Affected lot / code info: Model number 250-015-704. All serial/lot numbers.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: Worldwide Distribution--USA (nationwide) and countries of Brazil, Canada, Chili, Germany , Korea, Mexico, Philippines, Poland, Portugal, Singapore, Sweden, Switzerland, and Taiwan.

Timeline

Recall initiated: 2011-06-08
Posted by FDA: 2011-06-22
Terminated: 2011-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101010. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.