Recall Z-0326-2025 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Smith & Nephew, Inc.
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.
| Date | Nov 7, 2024 (initiated Oct 15, 2024) |
| Status | Open, Classified |
| Reason | The Bipolar assembly contains an oversized Retainer Ring. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters on and dated 15-Oct-2024 via email informing the consignee of the issue, patient impact, risks to health, and actions to be taken by the user. The actions include: 1. Ensure that the contents of this Field Safety Notice are read and understood by those within your organization who may use the Tandem Bipolar 46OD 28ID. 2. Locate and quarantine affected devices immediately. If you have further distributed the product to other organizations, please inform them at once of this Field Action and provide them with a copy of this letter. 3. Please complete the Cust |
| Quantity | 21 devices |
| Distribution | International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey. |
| FDA record | Open on fda.gov |