| Class 2 Device Recall PKG, OPVIOPSY FORCEPS, SPOON JAW | |
Date Initiated by Firm | November 17, 2014 |
Date Posted | December 12, 2014 |
Recall Status1 |
Terminated 3 on July 17, 2015 |
Recall Number | Z-0634-2015 |
Recall Event ID |
69838 |
Product Classification |
Endoscope and/or accessories - Product Code KOG
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Product | PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246.
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 |
140616 245976 340614 344497 444951 540952 643595 846782 847704 940162 941321 942551 943424 943445 943536 943537 945451 1040934 1041474 1041845 1042234 1042681 1042691 1042707 1141159 1141977 1143134 1144330 1145150 1145799 1146352 1240419 1240501 1241813 1242394 1242476 1243369 1244536 1245518 1341465 1341598 1341600 1343695 1344290 1345041 1345100 1345606 1346109 1346670 1440677 1440707 1440894 1440896 |
Recalling Firm/ Manufacturer |
Stryker Endoscopy 5900 Optical Ct San Jose CA 95138-1400
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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 |
Action | 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. |
Quantity in Commerce | 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 Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela. |
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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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