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Use caution Medical device recall · FDA · Published June 24, 2020

Smith & Nephew T-F1X0 RCG Drill Pac Recall: One Sleeve Missing in Surgical Drills

Smith & Nephew recalls surgical drill packs with one sleeve instead of two, risking improper bone tunnel drilling during rotator cuff repairs. Affected units include specific lot numbers from August 2023.

🇺🇸 FDA recall #Z-2702-2020Medical deviceSmith & Nephew ›
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Recalling firmSmith & Nephew, Inc.150 Minuteman Rd · Andover, MA 01810-1031
✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling surgical drill packs that contain only one sleeve instead of two. This means the device won't properly drill the second bone tunnel during rotator cuff repairs, potentially causing surgical errors. Read more at govinfonow.com/recall/64915-smith-nephew-t-f1x0-rcg-drill-pac-recall-one-sleeve.

Source Summary by GovInfoNow · govinfonow.com/recall/64915-smith-nephew-t-f1x0-rcg-drill-pac-recall-one-sleeve · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2702-2020

Cite this page

“Smith & Nephew T-F1X0 RCG Drill Pac Recall: One Sleeve Missing in Surgical Drills.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64915-smith-nephew-t-f1x0-rcg-drill-pac-recall-one-sleeve. Based on FDA recall #Z-2702-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2702-2020%22&limit=1).

The FDA announced on June 24, 2020, that Smith & Nephew, Inc. is recalling the Smith & Nephew T-F1X0 RCG Drill Pac due to a manufacturing defect. The hazard involves the sterile package containing only one sleeve instead of two, preventing intended performance for the second bone tunnel.

How to tell if you have it

  • Brand: Smith & Nephew
  • Product: Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves
  • Catalog Number: 014771
  • Lot Numbers: 2042492 and 2049408

The hazard

The T-Fix sterile package contains only one sleeve instead of two. Consequently, the device will not perform as intended for the second bone tunnel due to the absence of the sleeve.

Context

GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since July 24, 2017. Other recent recalls include the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), the Smith & Nephew BIOSURE HA Screw Recall (November 24, 2025), and the Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include the Orthalign Drill Plate Recall (February 10, 2026) and the Charlotte Claw Screw Recall (August 18, 2026).

How to tell if you have this one

Check for lot numbers 2042492 or 2049408 on the packaging. The product is sold for surgical arthroscopic rotator cuff repair procedures and was distributed starting August 28, 2023.

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

What to do — step by step

  1. Check Product Lot Number

    Look for lot numbers 2042492 or 2049408 on the packaging to identify affected units.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the state of CO and the countries of AT, BE, CH, CL, DE, DK, ES, FR, GB, IT. Expanded 8/28/20 recall: 2nd Field Action: AU, CH, DE, FR, GB, IT, NL, PL, PT, & ZA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Jun 24, 202012. FDA classified it Class II: Jul 24, 202023. Published in FDA’s Enforcement Report: Aug 5, 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-2702-2020 (June 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2702-2020 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