Z-2218-2016Class II

Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use

Name: Z-2218-2016 Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use
Creator: Smith & Nephew, Inc.
Published: 2016-06-15
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-06-15 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use on 2016-06-15. FDA classified it as Class II and gives the reason as "The device could be subject to breaches of its sterile packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2218-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-15
Posted: 2016-07-18
Terminated: 2021-03-22
Recalling firm: Smith & Nephew, Inc.
Product: Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
Product code: NBH Accessories, Arthroscopic
Reason for recall: The device could be subject to breaches of its sterile packaging.
Root cause tag: packaging
FDA 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 in commerce: 563
Distribution: Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.
Product codes and lots: Batch numbers: 50412843, 50477278, 50527184

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2218-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2218-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18

Product code NBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)