Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture
Medical device recall Z-2745-2016. Published in FDA’s Enforcement Report on Sep 14, 2016.
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 14, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 34,065 units 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?
Sterility compromised due to breach in sterile packaging
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
34,065 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot codes: 50387867 50388745 50389780 50390947 50392219 50392401 50393765 50394079 50395093 50396528 50396841 50397925 50399974 50400293 50401451 50402461 50402959 50403376 50403941 50405570 50406358 50407001 50407434 50407950 50407951…
Every code shown here, 2,000 characters
Lot codes: 50387867 50388745 50389780 50390947 50392219 50392401 50393765 50394079 50395093 50396528 50396841 50397925 50399974 50400293 50401451 50402461 50402959 50403376 50403941 50405570 50406358 50407001 50407434 50407950 50407951 50408878 50409545 50410397 50411389 50412044 50413155 50414113 50415145 50415520 50415873 50416326 50416832 50417399 50417668 50418103 50418994 50420164 50421033 50421623 50422190 50422891 50422892 50423320 50424442 50424933 50426325 50427350 50428379 50429275 50429625 50433984 50434656 50436573 50437136 50437526 50437759 50438338 50439087 50439765 50439766 50440062 50440837 50441687 50442651 50442880 50444065 50446669 50446768 50446770 50448070 50448602 50449028 50450098 50450473 50451227 50452947 50453834 50454699 50456357 50457059 50457933 50458614 50460363 50461194 50462494 50463802 50464798 50466235 50466505 50467033 50467808 50468830 50469933 50471415 50472190 50473438 50474159 50475156 50475855 50477527 50478007 50478622 50479617 50481285 50481730 50483050 50483361 50485995 50487659 50488891 50492846 50492847 50492848 50492849 50492851 50492852 50493064 50493806 50494458 50495857 50496836 50498479 50499120 50499121 50500273 50502177 50503259 50503943 50505008 50506627 50507250 50507728 50508689 50510084 50513573 50514115 50515369 50516858 50517711 50518586 50519608 50519938 50521068 50521840 50522157 50522313 50522481 50522791 50523907 50524119 50524707 50525171 50526231 50526605 50527117 50527848 50528880 50529519 50529834 50530093 50530468 50530782 50530799 50531351 50531553 50532380 50532717 50533143 50533646 50534235 50534638 50537501 50549463 50549468 50553176 50553177 50553178 50553585 50554431 50555221 50555642 50556017 50556125 50558051 50559082 50560192 50560193 50562713 50563407 50565147 50565408 50567384 50569692 50570896 50572075 50574212 50575366 50577597 50578036 50578037 50579348 50580730 50581344 50583475 50584361 50584362 50584363 50586084 50586561 50588245 50589286 50590542 50591919 50592295 50594969 50598322…
FDA’s list runs to 2,062 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. US nationwide, and the countries of: AU, AT, BE, CA, CH, CR, DB, DE, ES, FI, FR, GB, GR, IC, IL, IN, IT, MY, NL, NO, PL, PR, PT,SE, SG, TH, and ZA.
These words name no state.
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 Jul 19, 2016.
- FDA classified it on Sep 7, 2016.
- FDA’s Enforcement Report published it on Sep 14, 2016.
- FDA terminated it on Jul 10, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smith & Nephew, Inc., of Mansfield, 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 2,062 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.