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U.S. Department of Health and Human Services

Class 2 Device Recall PKG, BIPOLAR FORCEPS, FENESTRATED

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 Class 2 Device Recall PKG, BIPOLAR FORCEPS, FENESTRATEDsee related information
Date Initiated by FirmNovember 17, 2014
Date PostedDecember 12, 2014
Recall Status1 Terminated 3 on July 17, 2015
Recall NumberZ-0596-2015
Recall Event ID 69838
Product Classification Endoscope and/or accessories - Product Code KOG
ProductPKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 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.
Code Information 06CON06113 0816243/0817410 0913221/0817442 0913222/0817442 1015164/1014813 1015164/1015778 1016405/1016061 1016405/1016400 1016405/1016401 1113335/1113339 1213126/1114543 1213127/1114543 1213127/1213123 1214001/1313047 1313947/1313946 0817389/0817444 0913565/0913326 0915791/0915061 0915791/1013608 0915894/0915061 0915895/0915061 1014635/1015778 1015165/1013609 1015165/1015778 1015773/1015778 1015774/1015778 1015862/1016061 1016124/1016061 1016125/1016062 1016128/1016061 1016406/1016400 1016408/1016400 1016408/1016826 1016562/1016400 1113333/1016063 1113333/1113018 1113333/1113136 1113333/1113339 1115969/1115651 1116112/1115651 1116113/1115651 1116114/1115651 1116115/1115651 1116256/1115651 1213128/1213731 1213973/1213978 1213974/1213731 1213974/1213978 
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact
408-754-2000
Manufacturer 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 2
Error in labeling
ActionStryker 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.
Quantity in Commerce180,573 units total
DistributionWorldwide 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.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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