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.
Reported: November 13, 2024 Initiated: October 15, 2024 #Z-0326-2025
Product Description
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.
Reason for Recall
The Bipolar assembly contains an oversized Retainer Ring.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 21 devices
- Distribution
- International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smith & Nephew, Inc.. Units affected: 21 devices.
Why was this product recalled? ▼
The Bipolar assembly contains an oversized Retainer Ring.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0326-2025.
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