Recall Z-0624-2015

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, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. 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: 42178 42259 42260 42263 42267 42325 42326 42791 70109 713091 72309 90809 1192010 140575 140800 140807 140864 141289 141292 141401 0200154B 0200176B 0200177B 0245386C 0246314C 0246934C 0246939C 0246940C 0246942C 0247044C 0247047C 0247049C 0340029C 0340679C 0340680C 0340681C 0340682C 0340683C 0341237C 0341241C 0341908C 0341912C 4122011 04242012E 04282011E 0441389C 0441455C 0441456C 441457 0441461C 0441464C 0441465C 0441466C 0441467C 0441468C 0441471C 0441472C 0443282C 0443519C 5022011 5112010 5212010 52120101 52120102 52120103 52120104 05232013D 5252010 0540672D 0540867D 0540868D 0540869D 0540871D 0540872D 0540873D 0540874D 0540877D 0540878D 0540880D 0540881D 0540884D 06040590D 06122012E 6162014 6172011 6272012 06272012E 0640590D 0640591D 0640595D 0640596D 0640606D 0640607D 0640608D 640609 0640610D 0640611D 0640612D 0640613D 0640614D 0640615D 0647215D 06CON06064 06CON06123 06CON06666 7022012 7232014 0741767D 0741768D 0741770D 0741772D 0741773D 0741774D 0741776D 0741777D 0741778D 0745271D 0745276D 0745277D 0745278D 0745279D 0745280D 0745281D 0745282D 0840677D 0840768D 0841627D 0841630D 0841636D 0841640D 0841644D 0841648D 0841648E 0841652D 0841690D 0841699D 0841709D 0841720D 0842601D…

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-0624-2015
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