FDAFDA · Food and drugs·Recall number Z-0800-2013
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
Published February 20, 2013 · Recall initiated: April 18, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Expired product was shipped to two customers.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Bacterin International, Inc.
- Distributor
- Nationwide Distribution in TX , GA and CA.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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