Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner Recalled by Smith & Nephew, Inc. Due to The Bipolar assembly contains an oversized Retainer Ring.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smith & Nephew, Inc. directly.
Affected Products
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
Quantity: 21 devices
Why Was This Recalled?
The Bipolar assembly contains an oversized Retainer Ring.
Where Was This Sold?
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
About Smith & Nephew, Inc.
Smith & Nephew, Inc. has 220 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report