Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;
FDA device recall Z-0265-2012 · posted 2011-11-21 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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
- Date initiated
- 2011-10-24
- Date posted
- 2011-11-21
- Date terminated
- 2012-02-29
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER CROSSFIRE SYSTEM (K071859) | Stryker Endoscopy | 2007-09-20 |