FDA Medical devices recall ·
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring… recall
- Recall number
- Z-0326-2025
- Date
- (initiated October 15, 2024)
- Company / brand
- Smith & Nephew, Inc.
1450 E Brooks Rd, Memphis, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 21 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
The Bipolar assembly contains an oversized Retainer Ring.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch W2401399, UDI-DI 03596010494375.
Distribution
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0326-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.