Recall Z-0818-2016— Smith & Nephew, Inc., Endoscopy Div.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., Endoscopy Div., initiated 2013-07-30, terminated 2021-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.. Reason: During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery..
- Recalling firm
- Smith & Nephew, Inc., Endoscopy Div.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-30
- Terminated
- 2021-02-24
- Firm location
- Mansfield, MA, United States
Product description
High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
Reason for recall
During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.