Recall Z-0868-2009 ยท HRX Arthroscope
Stryker Endoscopy
Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802. The obturator is used to create an opening into the patient's joint and is removed after the cannula is inserted. The cannula then allows inst
| Date | Jan 16, 2009 (initiated Dec 1, 2008) |
| Status | Terminated |
| Reason | Leak: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed. |
| Root cause | Component change control |
| Action | Recall initiated 12/01/2008, Sales representatives were notified via telephone and e-mail. Product advisories entitled ""Urgent: Device Removal" and dated December 1, 2008, were sent to all consignees. All unused product is to be returned to the firm. For further information, please contact Stryker Endoscopy by telephone at 408-754-2124. |
| Quantity | 4,194 boxes (24,750 units) |
| Distribution | Worldwide Distribution --- including USA and countries of Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, New Zealand, Poland, Portugal, Sweden, Spain, Singapore, Switzerland, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944210 | ARTHROSCOPE ACCESSORIES Stryker Endoscopy, Feb 14, 1995 |