Date Initiated by Firm | April 18, 2012 |
Date Posted | 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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MBP
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