Smith & Nephew Bone Fixation Nail Recall: Packaging Error Risk
Smith & Nephew recalls bone fixation nails (TRIGEN INTERTAN) with model numbers 71675535 and 71675532 due to manufacturing packaging error. Affected units may have incorrect labeling.
Lower-risk recall
Manufacturing packaging error.
Contact the company
What happened, in plain English
Smith & Nephew is recalling bone fixation nails (TRIGEN INTERTAN) with specific model numbers because of a packaging error. This means the product might have incorrect labeling, which could lead to improper use. Read more at govinfonow.com/recall/64018-smith-nephew-bone-fixation-nail-recall-packaging-error-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/64018-smith-nephew-bone-fixation-nail-recall-packaging-error-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0772-2021
Cite this page
“Smith & Nephew Bone Fixation Nail Recall: Packaging Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64018-smith-nephew-bone-fixation-nail-recall-packaging-error-risk. Based on FDA recall #Z-0772-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0772-2021%22&limit=1).
Why it’s dangerous
A manufacturing packaging error means the product might have incorrect labeling. This could lead to improper use if the wrong model is used for a fracture. However, the error does not cause immediate harm in normal use.
Who’s affected
Patients who received bone fixation nails with model numbers 71675535 or 71675532 are likely affected. Medical professionals using these specific models are at higher risk due to potential labeling errors.
How to tell if you have this one
Check for model numbers 71675535 or 71675532 on the packaging. The lot numbers 20CM25278 and 20DM01466 are also associated with this recall.
- Brand
Smith & Neph: Inc.- Category
Medical device
What to do — step by step
Check Product Labeling
Look for model numbers 71675535 or 71675532 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Florida, Iowa, Kentucky, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Washington.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these nails?
No, the recall does not require stopping use; it only addresses potential labeling errors.
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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-0772-2021 (November 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0772-2021 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.