Smith & Neph: Tandem Bipolar Hip Component Recall Due to Oversized Retainer Ring
Smith & Nephew recalls Tandem Bipolar Hip System components with oversized retainer rings that could cause improper joint alignment during surgery. Affected units include specific model and batch numbers.
Lower-risk recall
The Bipolar assembly contains an oversized Retainer Ring.
Contact the company
What happened, in plain English
Smith & Nephew is recalling a specific hip joint component due to an oversized retainer ring that may cause improper alignment during surgery. This could lead to complications for patients receiving the implant. Read more at govinfonow.com/recall/53703-smith-neph-tandem-bipolar-hip-component-recall-due-to-oversized.
Source Summary by GovInfoNow · govinfonow.com/recall/53703-smith-neph-tandem-bipolar-hip-component-recall-due-to-oversized · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0326-2025
Cite this page
“Smith & Neph: Tandem Bipolar Hip Component Recall Due to Oversized Retainer Ring.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53703-smith-neph-tandem-bipolar-hip-component-recall-due-to-oversized. Based on FDA recall #Z-0326-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0326-2025%22&limit=1).
Why it’s dangerous
The oversized retainer ring may cause the hip joint to become misaligned during surgery. This could lead to improper function of the joint and potential complications for the patient after implantation.
Who’s affected
Patients who received the Tandem Bipolar Hip System with the specific model and batch number are affected. Surgeons using this component during procedures are at risk of improper implant alignment.
How to tell if you have this one
Check for the model number Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile. Affected units were manufactured in batch W2401399 with UDI-DI 03596010494375.
- Brand
Smith & Nephew- Category
Medical device
What to do — step by step
Check Product Details
Verify the model number and batch information to confirm if your component is affected.
How this recall unfolded
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
The recall is for a potential misalignment risk during surgery, but the hazard level is low risk as it does not cause immediate injury in normal use.
Similar recalls
Latest medical device recalls
Keep exploring
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-0326-2025 (October 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0326-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.