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U.S. Department of Health and Human Services

Class 2 Device Recall PKG, ATRAUMATIC FORCEPS, SINGLE ACTION

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 Class 2 Device Recall PKG, ATRAUMATIC FORCEPS, SINGLE ACTIONsee related information
Date Initiated by FirmNovember 17, 2014
Date PostedDecember 12, 2014
Recall Status1 Terminated 3 on July 17, 2015
Recall NumberZ-0672-2015
Recall Event ID 69838
Product Classification Endoscope and/or accessories - Product Code KOG
ProductPKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. 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 42714 43489 43490 143175 143176 143452 143453 340645 444574 641197 643520 647411 7108579 740242 840911 844136 848107 941058 942653 943254 943440 945124 1040231 1040393 1042255 1042649 1042650 1043453 1046589 1046699 1046906 1141173 1141190 1141384 1143126 1145283 1145682 1145977 1146679 1243100 1243539 1245517 1246171 1340193 1340476 1340586 1341582 1342389 1343704 1344285 1345531 1440912 1441963 1442257 1442810 1443396 
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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