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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Osteoselect Demineralized Bone Matrix DMB Putty 		see related information
Date Posted February 11, 2013
Recall Number Z-0800-2013
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
For Additional Information Contact Jalane M. Locke
406-388-0480
Reason for
Recall		 Expired product was shipped to two customers.
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.
 
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