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U.S. Department of Health and Human Services

Class 2 Device Recall OsteoSelect

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 Class 2 Recall
OsteoSelect
see related information
Date Posted April 17, 2013
Recall Status1 Terminated on July 01, 2013
Recall Number Z-1138-2013
Recall Event ID 64486
Premarket Notification
510(K) Number
K091321 
Product Classification Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) - 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, Montana 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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MBP and Original Applicant = BACTERIN INTERNATIONAL INC.
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