OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black
Medical device recall Z-2223-2013. Published in FDA’s Enforcement Report on Sep 25, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 25, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 18919 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
18919, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
50272332 50272462 50272750 50274144 50274350 50277105 50278907 50281510 50282171 50282827 50283849 50284637 50285830 50286658 50287767 50289371 50290043 50291934 50292091 50295383 50296070 50297228 50297782 50298793 50300135 50301932…
Every code shown here, 1,754 characters
50272332 50272462 50272750 50274144 50274350 50277105 50278907 50281510 50282171 50282827 50283849 50284637 50285830 50286658 50287767 50289371 50290043 50291934 50292091 50295383 50296070 50297228 50297782 50298793 50300135 50301932 50306856 50307462 50308037 50309210 50310436 50310780 50312090 50313439 50313818 50314915 50315807 50316601 50316986 50317483 50318001 50318687 50319907 50320679 50321916 50322244 50323257 50323630 50323780 50324608 50325611 50326067 50327821 50329242 50331546 50332253 50333092 50334400 50335620 50336405 50338241 50339832 50341062 50341605 50343271 50344262 50344618 50346215 50347305 50349093 50350513 50350978 50352032 50352701 50352997 50353606 50355123 50355672 50356987 50357104 50358206 50359714 50360454 50360914 50361413 50362647 50363190 50364588 50364909 50364915 50370316 50370385 50372675 50372728 50372892 50374025 50374503 50375408 50376044 50376238 50377316 50378706 50380530 50381197 50382647 50384163 50384950 50385362 50387220 50387886 50387896 50388742 50390996 50391608 50392266 50394701 50395538 50397273 50398231 50399415 50400574 50401262 50401918 50402459 50402823 50403367 50403718 50404238 50404920 50405868 50405869 50410769 50412026 50412957 50414254 50416317 50416526 50417204 50418001 50418331 50418992 50421031 50422577 50423435 50423591 50426460 50426933 50427032 50428116 50428624 50429271 50429999 50430000 50430400 50430503 50430504 50430505 50430657 50431379 50433038 50433039 50433040 50433041 50433127 50434653 50435732 50435733 50435734 50435809 50436890 50438659 50440452 50441439 50450277 50450752 50451781 50452210 50452585 50453453 50454295 50454418 50455195 50455483 50455813 50456909 50457385 50458416 50458475 50459739 50460097 50460240 50461060 50462482 50463458 50464108
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 6, 2013.
- FDA classified it on Sep 17, 2013.
- FDA’s Enforcement Report published it on Sep 25, 2013.
- FDA terminated it on Apr 20, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smith & Nephew, Inc. Endoscopy Division, of Andover, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.