CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report

Ultra-fast FIX Knot Pusher Suture Cutters Product Number recalled

Smith & Nephew is recalling Ultra-fast FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal, distributed nationwide in the US. The recall was initiated on 30 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019

Quantity recalled202,279 units

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-1822-2015
FDA event ID: 71257
Recalling firm: Smith & Nephew, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 30 Apr 2015
FDA classified: 22 Jun 2015
Reported: 1 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

30 Apr 2015	Recall initiated by company
22 Jun 2015	Classified by FDA	+53 days
1 Jul 2015	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

Sterility of device maybe compromised

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

ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

Where it was distributed

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.

Nationwide Puerto Rico

Questions about this recall

Is Ultra-fast FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal recalled?

Yes. Smith & Nephew recalled Ultra-fast FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal on 30 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1822-2015.

Why was it recalled?

Sterility of device maybe compromised

Which lots are affected?

All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019

Where was it sold?

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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