Class 2 Device Recall Electrical Power Cord

• Date Initiated by Firm: April 16, 2010
• Date Posted: January 19, 2011
• Recall Status: Terminated on January 19, 2011
• Recall Number: Z-0922-2011
• Recall Event ID: 56356
• 510(K)Number: K935234
• Product Classification: Laparoscope, general &, plastic surgery - Product Code GCJ
• Product: Stryker brand Cart with Isolation Transformer, ; Model Numbers: 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072.; ; 240-099-001,; 240-099-001K,; 240-099-011,; 240-099-011K,; 240-099-020,; 240-099-020K,; 240-099-050,; 240-099-072,; ; Product is manufactured and distributed by Stryker Endoscopy; San Jose, CA; The product is indicated for use in the carts include an isolation transfer and a power cord for connecting the transformer to an electrical outlet as means of providing power to the cart for the equipment it houses.
• Code Information: Model Numbers/First/Serial Numbers: 240-099-001, 240-099-001K; First Serial number: 070119AB001; 240-099-011, 240-099-011K; First Serial number :070112AD043; 240-099-020, 240-099-020K: First Serial number: 070123AG001 240-099-050; First Serial number: 061206AF001; 240-099-072; First Serial number: 081002AL001.
• Recalling Firm/ Manufacturer: Stryker Endoscopy; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: Michale Hilldoerfer; 408-754-2664
• Manufacturer Reason for Recall: The electrical cord power plug design may allow the prongs to develop a fracture inside or outside the plug, if the plug is misused.
• FDA Determined Cause: Device Design
• Action: Stryker Endoscopy sent an URGENT: Device Recall letter dated April 16, 2010, to Stryker Sales reps and all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Locate the affected units. Visually inspect each cord for damage. If the cord has bent or cracked prongs the unit should be taken out of service immediately. The customer was instructed to call a Regulatory Affairs Recall Representative at (408) 754-2738 for further instruction. If the cord did not show signs of damage, it could remain in service. An acknowledgement form was included to document confirmation of receipt of the letter. Upon completion of the power cord inspection, customers were to sign the acknowledgement form indicating that all of their units were inspected. Customers were asked to mail the form to Stryker Endoscopy or fax to (408) 754-8378 or scan the card and email to PowerCord@stryker.com. For questions regarding this recall call the Stryker RA/QA Department at (408) 754-2738 or (800) 435-0220, Reference RA 2010-034.
• Quantity in Commerce: 7371
• Distribution: Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, ME, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, MY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and the countries of Canada, Chile, China, India, Korea, Mexico, Singapore, Taiwan and Latin America.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = GCJ and Original Applicant = Stryker Endoscopy