Recall Z-0684-2015

Stryker Endoscopy · initiated November 17, 2014

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

PKG, BABCOCK FORCEPS, P/N 0250080321. 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.

Codes / lots: 140571 140572 140590 442506 542896 643523 646838 741305 741307 744923 842628 842632 842638 842640 847869 847870 847872 847873 847877 847878 847880 847881 847885 847886 1041276 1042935 1042951 1045190 1046166 1046900 1046901 1140664 1140821 1142174 1142665 1143446 1143728 1144692 1145109 1146164 1146165 1146388 1146900 1146901 1147163 1240407 1240955 1241953 1241954 1242409 1243807 1244132 1244241 1244441 1245480 1246060 1246405 1340290 1341254 1341835 1341836 1343535 1343993 1346493 1440592 1440788 1440789

Reason for recall

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

FDA-determined cause: Error in labeling

Action taken

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.

Details

Recall number
Z-0684-2015
Initiated
November 17, 2014
Posted by FDA
December 12, 2014
Terminated
July 17, 2015
Quantity
180,573 units total
Distribution
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…
Recalling firm
Stryker Endoscopy, San Jose, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0592-2015 Class IIPKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide:…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0593-2015 Class IIPKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0594-2015 Class IIPKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0595-2015 Class IIPKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0596-2015 Class IIPKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0597-2015 Class IIPKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0598-2015 Class IIPKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0599-2015 Class IIPKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0600-2015 Class IIPKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0601-2015 Class IIPKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0602-2015 Class IIPKG, PORTIO ACORN SMALL ONLY, P/N 0250080139; Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0603-2015 Class IIPKG, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0604-2015 Class IIPKG, OBTURATOR, 5.5MM FOR HASSON CANNULA, P/N 0250080157; Laparoscopic Manual…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0605-2015 Class IIPKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. Laparoscopic…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0606-2015 Class IIPKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0607-2015 Class IIPKG, HASSON CANNULA, 5.5MM, AUTOMATIC VALVE, STOP COCK, P/N 0250080176. Laparoscopic…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0608-2015 Class IIPKG, MIXTER FORCEPS, P/N 0250080010. Laparoscopic Manual Instruments are intended for…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0609-2015 Class IIPKG, HOOK SCISSORS, P/N 0250080020. Laparoscopic Manual Instruments are intended for…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0610-2015 Class IIPKG, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK, P/N 0250080179. Laparoscopic…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0611-2015 Class IIPKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0612-2015 Class IIPKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080024. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0613-2015 Class IIPKG, METZENBAUM SCISSORS, CURVED, LONG, P/N 0250080025. Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0614-2015 Class IIPKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028. Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0615-2015 Class IIPKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0616-2015 Class IIPKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0617-2015 Class IIPKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. Laparoscopic Manual…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0618-2015 Class IIPKG, LUERLOCK, MALE, 6MM TUBING, P/N 0250080207. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0619-2015 Class IIPKG, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0620-2015 Class IIPKG, MARYLAND FORCEPS, CURVED, LEFT, P/N 0250080042. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated
Z-0621-2015 Class IIPKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230. Laparoscopic Manual…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated