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

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

Smith & Nephew, Inc. Endoscopy Division is recalling Osteoraptor Suture Anchor with 2 Ultrabraid Suture, White / Blue, 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 codes50272329 50272466 50274208 50274464 50274790 50275814 50277799 50278266 50278994 50282166 50283019 50283839 50285057 50286656 50288421 50289813 50291359 50293118 50294563 50295608 50296649 50298065 50301017 50302318 50305467 50306821 50308347 50309211 50310089 50310614 50311296 50312591 50314389 50315223 50315419 50316180 50316679 50316987 50317481 50318376 50318532 50319543 50320363 50321935 50323084 50323631 50324184 50324789 50327218 50331339 50333094 50336659 50339177 50340628 50343607 50345140 50345975 50347750 50349688 50352034 50352998 50354277 50354523 50356122 50356984 50357948 50358554 50360002 50360656 50361750 50362641 50363887 50364918 50367858 50368809 50370314 50371912 50374779 50375720 50376835 50377822 50379209 50381376 50384165 50385364 50386748 50387839 50388736 50390940 50392275 50393329 50394520 50395793 50397073 50399277 50400560 50401454 50402073 50403117 50403703 50404630 50406026 50407298 50408207 50408986 50409815 50410646 50411754 50413578 50414258 50415462 50416319 50417212 50418095 50418678 50420659 50422216 50428378 50429372 50429659 50430185 50430406 50433943 50435810 50436716 50437246 50438205 50438744 50440212 50440606 50441444 50443360 50443860 50444062 50445142 50445316 50445551 50445552 50445553 50445555 50445556 50447139 50448325 50449126 50450279 50451524 50452588 50452764 50453646 50454691 50455485 50456543 50458419 50458609 50460107 50460693 50463955 50464113 50465465 50468475

Quantity recalled17696 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-2221-2013
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 / Blue ; Part Number: 72201995 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 / Blue recalled?

Yes. Smith & Nephew, Inc. Endoscopy Division recalled Osteoraptor Suture Anchor with 2 Ultrabraid Suture, White / Blue on 6 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2221-2013.

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?

50272329 50272466 50274208 50274464 50274790 50275814 50277799 50278266 50278994 50282166 50283019 50283839 50285057 50286656 50288421 50289813 50291359 50293118 50294563 50295608 50296649 50298065 50301017 50302318 50305467 50306821 50308347 50309211 50310089 50310614 50311296 50312591 50314389 50315223 50315419 50316180 50316679 50316987 50317481 50318376 50318532 50319543 50320363 50321935 50323084 50323631 50324184 50324789 50327218 50331339 50333094 50336659 50339177 50340628 50343607 50345140 50345975 50347750 50349688 50352034 50352998 50354277 50354523 50356122 50356984 50357948 50358554 50360002 50360656 50361750 50362641 50363887 50364918 50367858 50368809 50370314 50371912 50374779 50375720 50376835 50377822 50379209 50381376 50384165 50385364 50386748 50387839 50388736 50390940 50392275 50393329 50394520 50395793 50397073 50399277 50400560 50401454 50402073 50403117 50403703 50404630 50406026 50407298 50408207 50408986 50409815 50410646 50411754 50413578 50414258 50415462 50416319 50417212 50418095 50418678 50420659 50422216 50428378 50429372 50429659 50430185 50430406 50433943 50435810 50436716 50437246 50438205 50438744 50440212 50440606 50441444 50443360 50443860 50444062 50445142 50445316 50445551 50445552 50445553 50445555 50445556 50447139 50448325 50449126 50450279 50451524 50452588 50452764 50453646 50454691 50455485 50456543 50458419 50458609 50460107 50460693 50463955 50464113 50465465 50468475

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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