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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 Recall
Osteoselect Demineralized Bone Matrix DMB Putty
see related information
Date Posted February 11, 2013
Recall Status1 Terminated on May 13, 2013
Recall Number Z-0800-2013
Recall Event ID 63433
Premarket Notification
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, Montana 59714-9719
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: Error in Labeling
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 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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