Recall Z-2218-2016
Smith & Nephew, Inc. · initiated June 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
Codes / lots: Batch numbers: 50412843, 50477278, 50527184
Reason for recall
The device could be subject to breaches of its sterile packaging.
FDA-determined cause: Package design/selection
Action taken
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.
Details
- Recall number
- Z-2218-2016
- Initiated
- June 15, 2016
- Terminated
- March 22, 2021
- Product code
- NBH – Accessories, Arthroscopic
- Quantity
- 563
- Distribution
- Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.
- Recalling firm
- Smith & Nephew, Inc., Mansfield, MA