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U.S. Department of Health and Human Services

Class 2 Device Recall Palacos R

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  Class 2 Device Recall Palacos R see related information
Date Initiated by Firm January 17, 2003
Date Posted February 05, 2003
Recall Status1 Terminated 3 on September 12, 2003
Recall Number Z-0546-03
Recall Event ID 25497
PMA Number P810020 
Product Classification Bone Cement - Product Code LOD
Product Palacos R radiopaque bone cement, 40 gram. Product number 424800.
Code Information All lots.
Recalling Firm/
Biomet Inc
56 East Bell Dr
Warsaw IN 46582
For Additional Information Contact Paula Hoesel
800-348-9500 Ext. 1305
Manufacturer Reason
for Recall
There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.
FDA Determined
Cause 2
Action The firm issued recall letter for one lot dated January 21, 2003, but a subsequent letter dated January 21, 2003 expanded the recall to all lots. Customers are instructed to not use the product. They are to either return it to their local distributor, or to mix the cement and properly dispose of it themselves. [This is a hazardous material requiring special shipping methods.]
Quantity in Commerce 301,226 units
Distribution United States
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.
PMA Database PMAs with Product Code = LOD and Original Applicant = SMITH & NEPHEW RICHARDS, INC.