CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report

Twinfix Ultra Plla/HA Suture Anchor with 3 Ultrabraid Suture recalled

Smith & Nephew, Inc. Endoscopy Division is recalling Twinfix Ultra Plla/HA Suture Anchor with 3 Ultrabraid Suture, distributed nationwide in the US. The recall was initiated on 6 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes50324716 50324717 50326836 50336720 50336769 50337108 50337111 50339644 50339652 50339655 50339836 50340060 50341066 50341289 50341609 50341853 50342712 50344393 50345532 50349940 50375176 50377968 50378734 50380398 50382028 50385516 50386564 50387848 50391713 50392430 50395097 50395980 50396847 50399973 50400923 50402846 50405227 50406208 50406714 50408995 50410652 50411391 50412536 50415225 50415871 50416543 50417398 50428649 50429274 50429621 50429622 50429871 50436765 50436775 50437663 50440391 50443629 50446032 50446451 50446454 50446455 50447009 50447010 50453524

Quantity recalledN/A

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-2234-2013
FDA event ID: 66037
Recalling firm: Smith & Nephew, Inc. Endoscopy Division, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 6 Aug 2013
FDA classified: 17 Sep 2013
Reported: 25 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

6 Aug 2013	Recall initiated by company
17 Sep 2013	Classified by FDA	+42 days
25 Sep 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

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

TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor

Where it was distributed

Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.

Nationwide Puerto Rico

Questions about this recall

Is Twinfix Ultra Plla/HA Suture Anchor with 3 Ultrabraid Suture recalled?

Yes. Smith & Nephew, Inc. Endoscopy Division recalled Twinfix Ultra Plla/HA Suture Anchor with 3 Ultrabraid Suture on 6 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2234-2013.

Why was it recalled?

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Which lots are affected?

50324716 50324717 50326836 50336720 50336769 50337108 50337111 50339644 50339652 50339655 50339836 50340060 50341066 50341289 50341609 50341853 50342712 50344393 50345532 50349940 50375176 50377968 50378734 50380398 50382028 50385516 50386564 50387848 50391713 50392430 50395097 50395980 50396847 50399973 50400923 50402846 50405227 50406208 50406714 50408995 50410652 50411391 50412536 50415225 50415871 50416543 50417398 50428649 50429274 50429621 50429622 50429871 50436765 50436775 50437663 50440391 50443629 50446032 50446451 50446454 50446455 50447009 50447010 50453524

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.

More recalls from Smith & Nephew, Inc. Endoscopy Division

All 37

Reported	Class	Recall	Company	Reason	Where
23 Jul 2014Device	CLASS II	Suturefix Ultra Anchor XL recalled by Smith & Nephew, Inc.	Smith & Nephew, Inc. Endoscopy Division	Sterility	Nationwide
23 Jul 2014Device	CLASS II	Suturefix Ultra Anchor XL with one (#2) Ultrabraid Blue Product recalled	Smith & Nephew, Inc. Endoscopy Division	Sterility	Nationwide
23 Jul 2014Device	CLASS II	Suturefix Ultra S Double Loaded Suture Product recalled	Smith & Nephew, Inc. Endoscopy Division	Sterility	Nationwide
23 Jul 2014Device	CLASS II	Suturefix Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product recalled	Smith & Nephew, Inc. Endoscopy Division	Sterility	Nationwide
23 Jul 2014Device	CLASS II	Suturefix Ultra S with 1 #2 Ultrabraid (blue) Product recalled	Smith & Nephew, Inc. Endoscopy Division	Sterility	Nationwide

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