Recall Z-1704-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Endoscopy
Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.
| Date | Mar 17, 2011 (initiated Feb 25, 2010) |
| Status | Terminated |
| Reason | The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%). |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 31, 014 units |
| Distribution | Worldwide Distribution -- US, Australia, Canada, Germany, Greece, Iberia, Korea, Switzerland, and Newbury. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052141 | STRYKER STILETTO ELECTROSURGICAL PROBE Stryker Endoscopy, Oct 6, 2005 |