FDA Device recall Z-0822-2015
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented D…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented D… by Biomet, citing 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 Pol….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0822-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-02 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | n/a |
Product
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem 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.
Reason
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 34B Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.
Identifiers
| code_info | Sirius Polish Cemented Stem 348 Catalog Number: 51-199333 Lot Number Identification: 024320 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0822-2015%22
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