FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
- Recall number
- Z-2218-2016
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
- Status
- Terminated
- Initiated
- 2016-06-15
- Posted
- not on file
- Terminated
- 2021-03-22
- 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.
- Lot, serial or model codes
- Batch numbers: 50412843, 50477278, 50527184
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NBH
- Firm FEI
- 1219602
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28