Recall Z-0822-2015 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Biomet, Inc.
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
| Date | Dec 17, 2014 (initiated Dec 2, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| 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 audrey.daenzer@biomet.com, can be contacted from Monday through Friday 8 AM to 5 PM, 574-372-1570. |
| Quantity | 9 |
| Distribution | Foreign Distribution in China and Australia only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130610 | SIRIUS FEMORAL STEM Biomet, Inc., Aug 30, 2013 |