—#131805

Product

PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 33CM, P/N 0250080694 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: 44493 647221 647992 745498 842129 845882 846787 847844 940092 940153 941265 941741 944824 1040124 1040628 1041467 1042526 1042527 1043031 1043779 10441058 1044108 1045039 1045371 1046186 1046395 1046955 1047068 1140260 1141156 1141790 1142614 1144485 1145002 1145148 1145969 1146672 1240949 1241420 1241798 1242459 1243202 1244181 1244438 1244527 1244594 1245525 1245545 1246645 1340475 1341523 1342388 1343130 1343554 1344027 1344278 1344686 1346102 1440693 1441635 1443223

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 #131805. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.