BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture
Medical device recall Z-2215-2013. 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
- 43385 US 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?
BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
43385 US, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
50252371, 50252817, 50252818, 50253051, 50253556, 50254393, 50255140, 50255943, 50257230, 50257886, 50258390, 50258813, 50259145, 50259748, 50259820, 50260127, 50261934, 50263317, 50263909, 50264101, 50264417, 50264775, 50265257, 50265457,…
Every code shown here, 1,998 characters
50252371, 50252817, 50252818, 50253051, 50253556, 50254393, 50255140, 50255943, 50257230, 50257886, 50258390, 50258813, 50259145, 50259748, 50259820, 50260127, 50261934, 50263317, 50263909, 50264101, 50264417, 50264775, 50265257, 50265457, 50265935, 50266338, 50266709, 50266926, 50267287, 50267297, 50267742, 50268009, 50268284, 50268801, 50269502, 50269812, 50270227, 50270716, 50271271, 50271608, 50271908, 50272544, 50273015, 50273358, 50273640, 50273933, 50274557, 50274799, 50275368, 50276253, 50276254, 50276805, 50277029, 50277294, 50277527, 50277929, 50278456, 50278571, 50278899, 50279282, 50279628, 50279887, 50280270, 50280509, 50280951, 50281119, 50281654, 50281988, 50282538, 50282785, 50283315, 50283661, 50284261, 50284507, 50285047, 50285232, 50286292, 50286603, 50287484, 50287742, 50287951, 50288412, 50288413, 50288709, 50288711, 50289018, 50289361, 50289598, 50290037,50290863, 50291536, 50291656, 50292239, 50292240, 50292919, 50293285, 50293609, 50293897 50294168, 50294377, 50295055, 50295263 50296219 50296742 50297227 50297778 50297779 50297780 50298062 50298419 50298786 50299246 50299545 50299546 50299826 50300216 50300804 50301267 50301404 50302151 50302685 50303058 50303427 50303788 50303941 50304178 50304532 50305224 50305593 50306159 50306607 50306999 50307177 50307178 50307323 50307855 50308129 50308350 50308876 50309006 50309569 50309929 50310088 50310360 50310603 50311024 50311465 50311593 50312088 50312508 50312903 50313096 50313194 50313433 50313434 50313810 50313981 50314087 50314275 50314383 50314587 50314734 50314912 50315220 50315412 50315573 50316170 50316287 50316663 50316991 50317294 50317333 50317334 50319134 50319316 50319548 50319721 50320087 50320539 50320883 50321123 50321480 50321923 50322389 50322921 50323075 50323255 50323447 50323635 50323776 50324607 50326329 50327629 50327993 50331045 50328867 50329238 50331335 50331336 50331537 50332615 50332903 50333951 50334376 50335473 50336653 50337963 50338375 50339635 50340038 50340416…
FDA’s list runs to 3,086 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 3,086 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
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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.