—#131742

Product

PKG, SCHERTEL FORCEPS, FENESTRATED, P/N 0250080312. 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: 42933 140481 143691 143692 244219 246731 246732 247405 640116 646137 646140 744912 744915 749912 840178 842220 842235 842238 842344 847887 847888 847889 847891 847892 847893 847894 847895 847899 848003 941360 941362 941363 941365 941366 941367 941368 941372 941373 941374 1044887 1046603 1046606 1047025 1047026 1047027 1140203 1142289 1142290 1143095 1143703 1144245 1144724 1144725 1144726 1144727 1144728 1145801 1146163 1146376 1146728 1146729 1146983 1147051 1240178 1240179 1240362 1240957 1242410 1244440 1245119 1245120 1245121 1245511 1340288 1340721 1340722 1341833 1342683 1343533 1343991 1343992 140404 162099

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 #131742. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.