Recall Z-0301-2021— Smith & Nephew, Inc.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-09-21, terminated 2024-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 5.5MM Arthrogarde Hip Access Cannula. Reason: The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-21
- Terminated
- 2024-03-22
- Firm location
- Andover, MA, United States
Product description
5.5MM Arthrogarde Hip Access Cannula
Reason for recall
The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.