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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01270-1
Product Name/Description	Sirius Polish Cemented Stem 34B & Sirius Polish Cemented Stem 38C Sirius Polish Cemented Stem 34B Part Number: 51-199333 Lot Number: 024320 Sirius Polish Cemented Stem 38C Part Number: 51-199335 Lot Numbers: 141680, 180920 ARTG number: 223604
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	4/12/2014
Responsible Entity	Biomet Australia Pty Ltd
Reason/Issue	Following an investigation it has been identified that the component level lots were mixed during manufacturing. If the surgeon intended to implant a 34B but actually implanted a 38C, the potential adverse health outcome is a thin cement mantel which may lead to a revision, if the cement mantel were to crack. Additionally, the vertical and horizontal offsets may be larger than expected which may cause the patient to have potential leg length discrepancy and improper soft tissue tension (too tight). If the surgeon intended to implant a 38C but actually implanted a 34B, the potential adverse health outcome is the vertical and horizontal offsets may be smaller than expected which may cause the patient to have potential leg length discrepancy
Recall Action	Hazard Alert
Recall Action Instructions	Biomet is notifying surgeons of the safety implications of use of the incorrect size and advising surgeons to be aware of the issue during patient follow up. Further information can be found on the TGA web site at - http://www.tga.gov.au/alert/sirius-hip-stem-34b-and-38c-used-hip-replacements This action has been closed-out on 07/06/2016.
Contact Information	02 9878 6100 - Biomet Australia