Recall Z-0625-2015

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, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. 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: 41811 140622 140726 140727 140729 342723 345252 544042 544043 644785 645845 645850 645852 645854 648085 06CON06065 744231 744232 745522 746745 840675 842159 842161 842197 842207 846841 846842 846844 846845 846847 846848 846849 846850 846851 846853 846855 942926 942943 942944 942945 942946 942947 942950 942951 942953 942954 942960 942964 943554 1044584 1044800 1045871 1046151 1046152 1046159 1046162 1046165 1140204 1140205 1140659 1140660 1140662 1142190 1142191 1143092 1143093 1143436 1143437 1144693 1144694 1144696 1145106 1145400 1145478 1146161 1146982 1240188 1240189 1241117 1241949 1242400 1243129 1243584 1243585 1244442 1244882 1246186 1246187 1340352 1340493 1340494 1341007 1341164 1341880 1342685 1342858 1344252 1344707 1440353 1442562 1443626 544043 645847

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-0625-2015
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