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Lower risk Medical device recall · FDA · Published June 24, 2020

Smith & Nephew SUTUREFIX ULTRA Suture Recall: XL Drill Packaging Error

Smith & Nephew recalls SUTUREFIX ULTRA Suture (product 72203855) due to packaging error sending XL drill instead of S drill. This longer drill may cause injury during use.

🇺🇸 FDA recall #Z-2746-2020Medical deviceSmith & Nephew ›
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Contact the company

Recalling firmSmith & Nephew, Inc.150 Minuteman Rd · Andover, MA 01810-1031
✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling SUTUREFIX ULTRA Suture product 72203855 because a packaging error sent an XL drill instead of the S drill. The XL drill is one inch longer and could cause injury if used incorrectly. Read more at govinfonow.com/recall/64914-smith-nephew-suturefix-ultra-suture-recall-xl-drill-packaging-error.

Source Summary by GovInfoNow · govinfonow.com/recall/64914-smith-nephew-suturefix-ultra-suture-recall-xl-drill-packaging-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2746-2020

Cite this page

“Smith & Nephew SUTUREFIX ULTRA Suture Recall: XL Drill Packaging Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64914-smith-nephew-suturefix-ultra-suture-recall-xl-drill-packaging-error. Based on FDA recall #Z-2746-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2746-2020%22&limit=1).

The FDA announced on June 24, 2020, that Smith & Nephew, Inc. is recalling SUTUREFIX ULTRA Suture, product number 72203855, due to a packaging error. The hazard involves an XL drill being presented for use instead of the intended S drill. Owners should contact the company for further instructions.

How to tell if you have it

  • Brand: Smith & Nephew
  • Product: SUTUREFIX ULTRA Suture
  • Product number: 72203855
  • Lot numbers: 2038366, 2039311 and 2046505
  • Quantity: 868 units

The hazard

A packaging error resulted in an XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.

Context

GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025) and Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE Packaging Mix-Up Recall (Feb. 16, 2026) and EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (Feb. 16, 2026).

How to tell if you have this one

Check for SUTUREFIX ULTRA Suture with product number 72203855 and lot numbers 2038366, 2039311, or 2046505. The packaging error sent an XL drill instead of the S drill.

  • Brand
    Smith & Nephew
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product number and lot numbers to confirm if your SUTUREFIX ULTRA Suture is affected.

Where it went and when

Where it was distributed

Distributed in 22 states and Puerto Rico, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: not listedFLPuerto Rico: yesPR

FDA distribution: “Domestic distribution to AL AR AZ CO GA IL IN KS KY MD MN MO NC NE NJ NY OK PA PR TN TX VA WI. Foreign distribution to Australia Austria Belgium Finland France Germany Great Britain Ireland Italy Japan Luxembourg Mexico Netherlands Poland…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, Colorado, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Wisconsin.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Jun 24, 202012. FDA classified it Class II: Jul 31, 202023. Published in FDA’s Enforcement Report: Aug 12, 202032020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2746-2020 (June 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2746-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA