Recall Z-2218-2016 ยท NBH Accessories, Arthroscopic
Smith & Nephew, Inc.
Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
| Date | Jun 15, 2016 |
| Status | Terminated |
| Reason | The device could be subject to breaches of its sterile packaging. |
| Root cause | Package design/selection |
| Action | Urgent Recall Notification Letters were sent via Federal Express on June 15, 2016, to the customers listed in the firm's distribution report. Customers were asked to inventory their devices and contact the firm for return authorizations. |
| Quantity | 563 |
| Distribution | Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.