Recall Z-0603-2015

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, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; 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: 197 38131 38747 39045 39817 40278 44522 44930 44975 45335 45696 46073 46627 47127 47522 48166 48223 48343 48647 48697 48906 50041 50897 51785 51847 52851 55571 55760 56637 57449 59208 59912 61503 62135 63265 64479 66886 67927 69680 70038 70468 74244 75610 76094 76272 76376 76880 78068 81392 81963 83190 83798 84017 84488 87567 89064

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-0603-2015
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-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
Z-0622-2015 Class IIPKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… 11/17/2014Terminated