Bacterin Recalls Expired Osteoselect Demineralized Bone Matrix Putty
Bacterin International is recalling expired Osteoselect Demineralized Bone Matrix Putty shipped to customers in Texas, Georgia, and California.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves expired medical devices, which is a low-risk contamination or labeling issue without reported injuries, fitting the Moderate severity criteria.
Plain-English summary
Bacterin International, Inc. is recalling three packages of Osteoselect Demineralized Bone Matrix DMB Putty. The recalled products are bone void fillers indicated for the treatment of surgically created osseous defects. The specific units involved are Graft ID# B090056-664 and Graft ID# B090056-675, both associated with Donor# B090056 and an expiration date of 12/25/2011. Additionally, Graft ID# B100078-908 with an expiration date of 04/27/2012 was added to the recall on 07/12/2012.
The recall was initiated because the expired product was shipped to two customers. The distribution pattern for these units was nationwide, specifically within Texas, Georgia, and California.
Consumers and healthcare providers who have received these specific graft IDs should stop using the product and contact Bacterin International, Inc. for instructions on return or disposal.
The recalled product
- 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…
- Manufacturer
- Bacterin International, Inc.
- Category
- Medical Device — Bone Graft
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Graft ID# B090056-664 and Graft ID#: B090056-675
Distribution
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