—#131763

Product

PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA product code: KOG
Affected lot / code info: 513592 817411 817416 817475 817517 913167 913168 913323 913324 913522 913555 913556 913559 913560 913623 913624 913986 913987 913989 914273 914275 914276 914277 914474 914753 914754 1014636 1014637 1016127 1016731 1016732 1016733 1113017 1113021 1113023 1113183 1114206 1114207 1114208 1114629 1114630 1114631 1114636 1115403 1115404 1115405 1115406 1115928 1115967 1115968 1115972 1116257 1116654 1116655 1116656 1116720 1213970 1213971 1213972 1214400 1214969 1214970 1215122 1216019 1216020 1216021 1216022 1216819 1216820 1216821 1217044 1313484 1313487 1313488 1313935 1313936 1314206 1314207 1314208 1314691 1314692 1314693 1314694 1314927 1314975 1410317

Why it was recalled

The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

Root cause (FDA determination)

Error in labeling

Action the firm took

Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

Timeline

Recall initiated: 2014-11-17
Posted by FDA: 2014-12-12
Terminated: 2015-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131763. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.