Recall record at a glance
| Official record | Z-0823-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Biomet, Inc. |
| Report date | Dec 24, 2014 |
| Recall initiation date | Dec 2, 2014 |
| Quantity | 8 |
| Location | Warsaw, IN, United States |
Official product description
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.
Why the product was recalled
After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 348 Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.
Distribution information
Foreign Distribution in China and Australia only.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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