Smith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
Smith & Nephew is recalling 21 units of a Tandem Bipolar Hip System component due to an oversized retainer ring in the femoral head assembly. The affected devices were distributed internationally to nine countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a manufacturing defect in an orthopedic implant component. An oversized retainer ring represents a risk-of-harm defect in a medical device with no reported adverse events, meeting the rubric criterion for High severity.
Plain-English summary
Smith & Nephew, Inc. is recalling 21 sterile units of the Tandem Intl Bipolar Cocr Shell/UHMWPE Liner component of the Tandem Bipolar Hip System (REF 71324046). This component serves as the femoral head bipolar assembly in hip replacement procedures.
The recall was initiated because the bipolar assembly in the recalled units contains an oversized retainer ring. The affected devices are from batch W2401399 (UDI-DI 03596010494375).
The affected devices were distributed internationally to healthcare facilities in Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
Patients and healthcare providers with questions about this recall should contact Smith & Nephew for guidance regarding the implant component.
The recalled product
- 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.
- Manufacturer
- Smith & Nephew, Inc.
- Category
- Medical Device — Hip Implant
- Hazard
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch W2401399
- UDI-DI 03596010494375.
Distribution
Distribution scope not specified by the agency.
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