Smith & Nephew POLARSTEM Femoral Stems Recall: Cardan Joint Fracture Risk
Smith & Nephew recalls POLARSTEM femoral stems with Ti/HA (Standard, Lateral, Valgus, Collar) due to potential Cardan joint fracture after multiple surgeries. Affected units have specific lot numbers.
Stop using this now
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Contact the company
What happened, in plain English
Smith & Nephew is recalling certain POLARSTEM femoral stems that could fracture or fail after multiple surgeries. This risk is serious for patients who have had multiple hip replacements using these stems. Read more at govinfonow.com/recall/73367-smith-nephew-polarstem-femoral-stems-recall-cardan-joint-fracture-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73367-smith-nephew-polarstem-femoral-stems-recall-cardan-joint-fracture-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-3100-2017
Cite this page
“Smith & Nephew POLARSTEM Femoral Stems Recall: Cardan Joint Fracture Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73367-smith-nephew-polarstem-femoral-stems-recall-cardan-joint-fracture-risk. Based on FDA recall #Z-3100-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3100-2017%22&limit=1).
Why it’s dangerous
The Cardan joint in the stem can fracture or stop working after multiple surgeries. This could cause the stem to become loose or dislocated, leading to pain and potential complications.
Who’s affected
Patients who received the recalled POLARSTEM femoral stems (Standard, Lateral, Valgus, Collar types) with lot numbers A57835, A57837, A58509, A59084, A59446, A59547, or A60948 are affected. Surgeons and patients who have had multiple hip replacements using these stems are at highest risk.
How to tell if you have this one
Check the lot number on the stem packaging or surgical instrument. The recalled stems have specific lot numbers: A57835, A57837, A58509, A59084, A59446, A59547, or A60948. These stems are used in hip replacements and require a surgeon to implant them.
- Brand
Smith & Nephew- Category
Medical device
What to do — step by step
Stop Using It Now
Immediately stop using the recalled POLARSTEM femoral stems with the specified lot numbers if you have them.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.” 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 terminated this recall 3.1 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.
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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-3100-2017 (July 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3100-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.