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U.S. Department of Health and Human Services

Class 2 Device Recall Osteoselect Demineralized Bone Matrix DMB Putty

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  Class 2 Device Recall Osteoselect Demineralized Bone Matrix DMB Putty see related information
Date Initiated by Firm April 18, 2012
Date Posting Updated February 11, 2013
Recall Status1 Terminated 3 on May 13, 2013
Recall Number Z-0800-2013
Recall Event ID 63433
510(K)Number K091321  
Product Classification Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
Product Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects.

On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012
Code Information Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor# B090056 and Expiration Date: 12/25/2011.

A thrid graft with ID# B100078-908 expiration date 04/27/2012 was added to the recall 7/12/2012.
Recalling Firm/
Manufacturer
Bacterin International, Inc.
600 Cruiser Ln
Belgrade MT 59714-9719
For Additional Information Contact Jalane M. Locke
406-388-0480
Manufacturer Reason
for Recall
Expired product was shipped to two customers.
FDA Determined
Cause 2
Incorrect or no expiration date
Action Bacterin International phoned the two customers and they were instructed to return any of the unused product. For questions regarding this recall call 406-388-0480. The 3rd expired product was discovered by Bacterin Sales Rep 7/12/2012 at the consignee.
Quantity in Commerce 3 packages each containing 2.5cc of putty
Distribution Nationwide Distribution in TX , GA and CA.
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 and Original Applicant = BACTERIN INTERNATIONAL INC.
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