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Terminated

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

FDA Recall Z-0800-2013 · Posted 2013-02-11

Recalling FirmBacterin International, Inc.
Recall StatusTerminated
Product CodeMBP
Date Initiated2012-04-18
Date Terminated2013-05-13
Product Quantity3 packages each containing 2.5cc of putty

Reason for Recall

Expired product was shipped to two customers.

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

Nationwide Distribution in TX , GA and CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091321OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc. · 2009-09-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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