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Lower risk Medical device recall · FDA · Published September 20, 2021

Smith & Nephew 6.5MMX165MM Cannulated Screw Recall: Label Error

Smith & Nephew recalls 6.5MMX165MM cannulated screws due to incorrect threading label. Affected models may have partial threading instead of full threading.

🇺🇸 FDA recall #Z-0143-2022Medical deviceSmith & Neph: Inc. ›
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Contact the company

Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804
✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling 6.5MMX165MM cannulated screws because the product label claims they're fully threaded, but the actual screws are partially threaded. This could lead to improper use in medical procedures. Read more at govinfonow.com/recall/61789-smith-nephew-6-5mmx165mm-cannulated-screw-recall-label-error.

Source Summary by GovInfoNow · govinfonow.com/recall/61789-smith-nephew-6-5mmx165mm-cannulated-screw-recall-label-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0143-2022

Cite this page

“Smith & Nephew 6.5MMX165MM Cannulated Screw Recall: Label Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61789-smith-nephew-6-5mmx165mm-cannulated-screw-recall-label-error. Based on FDA recall #Z-0143-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0143-2022%22&limit=1).

Smith & Nephew, Inc. recalled 6.5MMX165MM CANNULATED SCREWS due to labeling errors indicating full threading when screws are partially threaded, according to the FDA on September 20, 2021.

How to tell if you have it

  • Brand: Smith & Nephew, Inc.
  • Product: 6.5MMX165MM CANNULATED SCREW
  • Model: 71106365S
  • Lot: 20GT39417
  • Quantity: 5 units

The hazard

The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

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 BIOSURE HA Screw Recall (November 24, 2025) and Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025).

How to tell if you have this one

Check for the model number 71106365S and lot number 20GT39417 on the packaging. The screws are sold under the brand Smith & Nephew.

  • Brand
    Smith & Neph: Inc.
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Verify the threading type on the screw label to ensure it matches the product description.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Oklahoma, Tennessee.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Sep 20, 202112. FDA classified it Class II: Oct 19, 202123. Published in FDA’s Enforcement Report: Oct 27, 202134. FDA terminated the recall: Mar 24, 2023420212023
  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.

✎ GovInfoNow

Questions people ask

Is there a risk of injury from this screw?

The recall indicates a potential for improper surgical fixation, but no specific injury risks are mentioned.

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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-0143-2022 (September 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0143-2022 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