Recall Z-0265-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Endoscopy
Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;
| Date | Nov 21, 2011 (initiated Oct 24, 2011) |
| Status | Terminated |
| Reason | An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011. |
| Root cause | Component design/selection |
| Action | Stryker Endoscopy Urgent Medical Device Removal notifications datyed October 25, 2011, were sent to all consignees via traceable mail. Sales representatives and regional managers were notified by e-mail. Product is to be returned to Stryker Endoscopy using the pre-paid shipping label. Replacement product may be obtained by calling Stryker at 1-800-624-4422. The enclosed Acknowledgement receipt form is to be completed and returned. Questions or comments may be directed to Stryker at 1-800-624-4422 or e-mail at 90S@stryker.com. |
| Quantity | 6307 |
| Distribution | Worldwide distribution including USA, Australia, Canada, China, Greece, Hong Kong, India, Italy, Japan, France, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland and the United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071859 | STRYKER CROSSFIRE SYSTEM Stryker Endoscopy, Sep 20, 2007 |