| | Class 2 Device Recall PKG, MINI METZENBAUM SCISSORS, CURVED LONG, |  |
| Date Initiated by Firm | November 17, 2014 |
|---|
| Date Posted | December 12, 2014 |
|---|
| Recall Status1 |
Terminated 3 on July 17, 2015 |
| Recall Number | Z-0645-2015 |
|---|
| Recall Event ID |
69838 |
| Product Classification |
Endoscope and/or accessories - Product Code KOG
|
| Product | PKG, MINI METZENBAUM SCISSORS, CURVED LONG, P/N 0250080266.
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 |
644425 647618 740284 740286 740636 747707 846469 847448 847698 941706 942884 944092 945218 945721 945978 1040106 1040384 1040591 1040980 1042651 1042652 1046111 1140150 1141221 1142911 1143081 1143802 1144941 1146981 1240108 1240979 1241812 1242922 1243456 1243541 1244535 12446651 1244709 1245454 1246133 1246651 1340100 1342147 1342763 1343294 1343295 1344295 1344525 1345290 1345421 1345528 1440445 1441381 1442043 |
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 |
|---|
| 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 |
|---|
| 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. |
|---|
|
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.
|
|
|
|
