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Lower risk Medical device recall · FDA · Published March 7, 2018

Smith & Nephew D-RAD Screws Recall: Over-tolerance risk in fracture kits

Smith & Neph: D-RAD Self-Tapping Locking Screws (Lot 17GM04522) may have over-tolerance threads causing improper fracture fixation. Affected patients should contact manufacturer for details.

🇺🇸 FDA recall #Z-1317-2018Medical deviceSmith & Nephew ›
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Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804
✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling a specific batch of D-RAD Self-Tapping Locking Screws used in distal radius fracture repairs. The screws in this batch were machined slightly too large, which could lead to improper bone fixation and potential complications during healing. Read more at govinfonow.com/recall/71753-smith-nephew-d-rad-screws-recall-over-tolerance-risk-in.

Source Summary by GovInfoNow · govinfonow.com/recall/71753-smith-nephew-d-rad-screws-recall-over-tolerance-risk-in · Updated August 27, 2026 · FDA enforcement record: FDA #Z-1317-2018

Cite this page

“Smith & Nephew D-RAD Screws Recall: Over-tolerance risk in fracture kits.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71753-smith-nephew-d-rad-screws-recall-over-tolerance-risk-in. Based on FDA recall #Z-1317-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1317-2018%22&limit=1).

The FDA announced on March 7, 2018, that Smith & Nephew, Inc. voluntarily recalled one lot of D-RAD Self-Tapping Locking Screws due to manufacturing specifications errors. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Smith & Nephew
  • Product: D-RAD Self-Tapping Locking Screw
  • Model/Ref: 74692410
  • Lot Number: 17GM04522
  • Quantity: 59 units

The hazard

One lot of D-RAD Self-Tapping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. The screws measured over tolerance within the head thread form by 0.002-0.003 inch.

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 Synthes 2.4V TAP CORTEX SCREW Recall (Feb. 25, 2026) and Orthalign Drill Plate Recall (Feb. 10, 2026).

How to tell if you have this one

Check for the Lot Number 17GM04522 on the packaging of D-RAD Self-Tapping Locking Screws (2.4MM x 10MM, sterile, REF 74692410) used in distal radius fracture kits.

  • 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 Number 17GM04522 on the packaging of the D-RAD Self-Tapping Locking Screws.

Where it went and when

Where it was distributed

Distributed nationwide.

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: yesFLPuerto Rico: yesPR

FDA distribution: “US, Puerto Rico, Malaysia” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Mar 7, 201812. FDA classified it Class II: Apr 6, 201823. Published in FDA’s Enforcement Report: Apr 18, 201834. FDA terminated the recall: Oct 31, 201842018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-1317-2018 (March 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1317-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 27, 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