Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553,
FDA device recall Z-1704-2011 · posted 2011-03-17 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).
- Action taken
- All Sales reps were notified of the recall on February 25, 2010. Urgent Device Removal advisory notices were also sent to all consignees.Device Removal letters identified the specific part numbers and lot numbers involved. Letters also list the potential risk to patients as a result of the issue. Customers are asked to inspect their inventory for part and lot numbers and quarantine any affected product. If recalled product is found, customers are to contact Stryker Customer Service at 800-624-4422 and request an RMS to send back recalled units. New units will be provided at no charge. The acknowledgement form is to be completed and returned. Questions or concerns should be directed to 408-754-2000 or e-mail at eprobe@stryker.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 31, 014 units
- Distribution
- Worldwide Distribution -- US, Australia, Canada, Germany, Greece, Iberia, Korea, Switzerland, and Newbury.
- Date initiated
- 2010-02-25
- Date posted
- 2011-03-17
- Date terminated
- 2011-03-18
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER STILETTO ELECTROSURGICAL PROBE (K052141) | Stryker Endoscopy | 2005-10-06 |