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 instruments and scopes access to the joint while maintaining a seal against the loss of saline fluid used to keep the joint clean. The seal is formed by two elastomeric valves. The first controls loss of water when there is no instrument or scope therein, while the second provides a seal when the cannula is in use. The valves operate automatically. Manufactured by Stryker Endoscopy Puerto Rico
FDA Recall Z-0868-2009 · Posted 2009-01-16
Advertisement
Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHRX
Date Initiated2008-12-01
Date Terminated2011-01-10
Product Quantity4,194 boxes (24,750 units)
Reason for Recall
Leak: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.
Firm 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.
Root Cause
Component change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement