Recall Z-0301-2021 ยท NBH Accessories, Arthroscopic
Smith & Nephew, Inc.
5.5MM Arthrogarde Hip Access Cannula
| Date | Sep 21, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | On 9/21/2020 the firm send a notification to its consignees with the following instructions: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3 |
| Quantity | 143 units |
| Distribution | Domestic Distribution: CA, CO, CT, GA, IA, IL, IN, MD, MO, NC, NY, OH, PA, SC, TN, TX, WA, WI, WV. International Distribution: AU, BR, CA, CL, CN, CO, DE, ES, GB, HK, KR, PA, PT, TW. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.