CLASS II ONGOING Device recall · Reported 13 Nov 2024 · FDA Enforcement Report
Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew
Smith & Nephew is recalling Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner, TI-6AL-4V Retaining Ring I.D, distributed nationwide in the US. The recall was initiated on 15 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0326-2025
- FDA event ID
- 95568
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Oct 2024
- FDA classified
- 7 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 15 Oct 2024 | Recall initiated by company | |
| 7 Nov 2024 | Classified by FDA | +23 days |
| 13 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Bipolar assembly contains an oversized Retainer Ring.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
Questions about this recall
Is Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner, TI-6AL-4V Retaining Ring I.D recalled?
Yes. Smith & Nephew recalled Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner, TI-6AL-4V Retaining Ring I.D on 15 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0326-2025.
Why was it recalled?
The Bipolar assembly contains an oversized Retainer Ring.
Which lots are affected?
Batch W2401399, UDI-DI 03596010494375.
Where was it sold?
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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