CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report
Twinfix Quick-t Knot Pusher Suture Cutter recalled by Smith & Nephew
Smith & Nephew is recalling Smith and Nephew Twinfix Quick-t Knot Pusher Suture Cutter, distributed nationwide in the US. The recall was initiated on 15 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2218-2016
- FDA event ID
- 74449
- Recalling firm
- Smith & Nephew, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2016
- FDA classified
- 18 Jul 2016
- Reported
- 27 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 15 Jun 2016 | Recall initiated by company | |
| 18 Jul 2016 | Classified by FDA | +33 days |
| 27 Jul 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device could be subject to breaches of its sterile packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
Where it was distributed
Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.
Questions about this recall
Is Twinfix Quick-t Knot Pusher Suture Cutter recalled?
Yes. Smith & Nephew recalled Twinfix Quick-t Knot Pusher Suture Cutter on 15 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2218-2016.
Why was it recalled?
The device could be subject to breaches of its sterile packaging.
Which lots are affected?
Batch numbers: 50412843, 50477278, 50527184
Where was it sold?
Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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