| Class 2 Device Recall PKG, TROCAR 5.5MM PYRAMIDAL TIP | |
Date Initiated by Firm | November 17, 2014 |
Date Posted | December 12, 2014 |
Recall Status1 |
Terminated 3 on July 17, 2015 |
Recall Number | Z-0603-2015 |
Recall Event ID |
69838 |
Product Classification |
Endoscope and/or accessories - Product Code KOG
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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. |
Code Information |
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 |
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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