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

Osteoraptor Suture Anchor with 2 Ultrabraid Suture, White / Black recalled

Smith & Nephew, Inc. Endoscopy Division is recalling Osteoraptor Suture Anchor with 2 Ultrabraid Suture, White / Black, 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 codes50272330 50272467 50274209 50274465 50274791 50275815 50277800 50292667 50296071 50302316 50306994 50310605 50311297 50316179 50318681 50321243 50323086 50325048 50325601 50326880 50329010 50329811 50334408 50336660 50338997 50340629 50344015 50346092 50346624 50353156 50354524 50356989 50358564 50363890 50364919 50368628 50370206 50374882 50376601 50378711 50381816 50385513 50390999 50391628 50392410 50395539 50400939 50403274 50404746 50406677 50408208 50409818 50412886 50414333 50415150 50416320 50417391 50418417 50419567 50421499 50431562 50433945 50436052 50437097 50439085 50445036 50445557 50447140 50449470 50450754 50452349 50453811 50454844 50456056 50458436 50461697

Quantity recalled5873 US

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-2225-2013
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

OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 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 Osteoraptor Suture Anchor with 2 Ultrabraid Suture, White / Black recalled?

Yes. Smith & Nephew, Inc. Endoscopy Division recalled Osteoraptor Suture Anchor with 2 Ultrabraid Suture, White / Black on 6 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2225-2013.

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?

50272330 50272467 50274209 50274465 50274791 50275815 50277800 50292667 50296071 50302316 50306994 50310605 50311297 50316179 50318681 50321243 50323086 50325048 50325601 50326880 50329010 50329811 50334408 50336660 50338997 50340629 50344015 50346092 50346624 50353156 50354524 50356989 50358564 50363890 50364919 50368628 50370206 50374882 50376601 50378711 50381816 50385513 50390999 50391628 50392410 50395539 50400939 50403274 50404746 50406677 50408208 50409818 50412886 50414333 50415150 50416320 50417391 50418417 50419567 50421499 50431562 50433945 50436052 50437097 50439085 50445036 50445557 50447140 50449470 50450754 50452349 50453811 50454844 50456056 50458436 50461697

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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