—#131750

Product

33CM DORSEY GRASPER FORCEPS, P/N 0250080319. 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: 23600 247034 444470 542723 543906 641202 744068 747134 844302 940160 940347 943637 943669 944095 944199 944200 944217 945746 1040595 1040649 1040983 1042091 1042930 1042931 1042932 1042933 1045029 1045896 1045897 1140649 1141565 1141566 1142269 1143078 1143340 1144348 1144501 1144933 1144934 1145345 1145346 1145680 1145681 1146468 1146469 1146846 1146847 1240114 1240115 1241424 1241425 1241426 1242123 1242124 1242125 1242933 1242934 1245715 1245716 1245717 124597 1245974 1245975 1246057 1340291 1340715 1340716 1341252 1341834 1343135 1343534 1344250 1344498 1346554 1441858 250080319 383699 646009

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 #131750. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.