Reported Feb 20, 2013 · Terminated
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056…
Bacterin International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bacterin International, Inc. · 600 Cruiser Ln · Belgrade, MT · 59714-9719
Is this the product you have?
- Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc
- Expiration Date12/25/2011
- LBL 210-0010-1 REV040109; 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
- Lot codes and dates
- Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor#
- B090056 and Expiration Date12/25/2011. A thrid graft with ID# B100078-908 expiration date 04/27/2012 was added to the recall 7/12/2012
- Amount recalled
- 3 packages each containing 2.5cc of putty
Where it was sold
Why it was recalled
Expired product was shipped to two customers.
This product could cause temporary or reversible health problems — stop using it.
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