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U.S. Department of Health and Human Services

Class 2 Device Recall Sirius Polish Cemented Stem 34B

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  Class 2 Device Recall Sirius Polish Cemented Stem 34B see related information
Date Initiated by Firm December 02, 2014
Date Posted December 17, 2014
Recall Status1 Terminated 3 on October 27, 2015
Recall Number Z-0822-2015
Recall Event ID 69932
510(K)Number K130610  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
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.
Code Information Sirius Polish Cemented Stem 348 Catalog Number: 51-199333 Lot Number Identification: 024320
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639
Manufacturer 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 34B Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.
FDA Determined
Cause 2		 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 in Commerce 9
Distribution Foreign Distribution in China and Australia only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JDI and Original Applicant = BIOMET, INC.
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