Class 2 Device Recall Disposable Dowel Harvest Tube

• Date Initiated by Firm: July 01, 2010
• Date Posted: September 28, 2010
• Recall Status: Terminated on August 20, 2012
• Recall Number: Z-2602-2010
• Recall Event ID: 56522
• Product Classification: Bone Coring Device - Product Code LXH
• Product: 8 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.; ; Usage: Bone Coring Device used in ACL and PCL procedures.
• Code Information: 648210 and 648220.,
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: Mary Johnson; 574-267-6639 Ext. 1676
• Manufacturer Reason for Recall: The affected instruments are discolored and/or have a sticky residue on the end.
• FDA Determined Cause: Packaging change control
• Action: The firm sent out "Urgent Medical Device Recall" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product. Questions relating to this recall should be directed to 574-371-3755.
• Quantity in Commerce: 100
• Distribution: US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
• 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.