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Class 2 Device Recall Sirius Polish Cemented Stem 34B |
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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
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Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
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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
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For Additional Information Contact |
Audrey Daenzer 574-267-6639
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = JDI and Original Applicant = BIOMET, INC.
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