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.
The Bipolar assembly contains an oversized Retainer Ring.
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.
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.
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.
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.
Verify the model number and batch information to confirm if your component is affected.
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.
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, and batch W2401399 with UDI-DI 03596010494375.
The recall does not specify a remedy, so contact Smith & Nephew directly for guidance.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0326-2025 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0326-2025 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
