Class 2 Device Recall OsteoSelect

• Date Initiated by Firm: February 21, 2013
• Date Posted: April 17, 2013
• Recall Status: Terminated on July 01, 2013
• Recall Number: Z-1138-2013
• Recall Event ID: 64486
• 510(K)Number: K091321
• Product Classification: Filler, bone void, calcium compound - Product Code MBP
• Product: OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
• Code Information: B100164 and B110115
• Recalling Firm/ Manufacturer: Bacterin International, Inc.; 600 Cruiser Ln; Belgrade MT 59714-9719
• For Additional Information Contact: Casey Ming, CTBS; 406-388-0480
• Manufacturer Reason for Recall: The firm's retesting procedure was not validated.
• FDA Determined Cause: Process control
• Action: Bacterin sent a Voluntary Product Recall Notification letter via e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are being asked to return any remaining product by obtaining a Return Authorization number from them. Bacterin is also asking customers to return the verification form mailed with the recall letter regardless of whether or not they had any product on hand. For questions contact Bacterin sales representative or Bacterin Customer Service.
• Quantity in Commerce: 165
• Distribution: USA Nationwide Distribution
• 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 = MBP