Bacterin International, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0800-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 18, 2012

Date Posted: February 20, 2013

Recall Number: Z-0800-2013

Event ID: 63433

Reason for Recall:

Expired product was shipped to two customers.

Status: Terminated

Product Quantity: 3 packages each containing 2.5cc of putty

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.

Distribution Pattern:

Nationwide Distribution in TX , GA and CA.

Voluntary or Mandated:

Voluntary: Firm initiated