Class 2 Device Recall Palacos R

• Date Initiated by Firm: January 17, 2003
• Date Posted: February 05, 2003
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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