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.
FDA Recall Z-0823-2015 · Posted 2014-12-17
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2014-12-02
Date Terminated2015-10-27
Product Quantity8
Reason for Recall
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.
Firm Action
Sent notices to customers dated 12/2/2014 notifying them of the recall: 5 were implanted, 3 were shipped to subsidiary for testing, and 2 are in Biomet control. Public Contact for the recall is: Audrey Daenzer, Field Action Specialist, Regulatory Compliance [email protected], can be contacted from Monday through Friday 8 AM to 5 PM, 574-372-1570.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Foreign Distribution in China and Australia only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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