Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5c
FDA device recall Z-0800-2013 · posted 2013-02-11 · Terminated
Recall details
- Recalling firm
- Bacterin International, Inc.
- Reason for recall
- Expired product was shipped to two customers.
- Action taken
- 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
- Status
- Terminated
- Product code
- MBP
- Quantity affected
- 3 packages each containing 2.5cc of putty
- Distribution
- Nationwide Distribution in TX , GA and CA.
- Date initiated
- 2012-04-18
- Date posted
- 2013-02-11
- Date terminated
- 2013-05-13
- Location
- Belgrade, MT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (K091321) | Bacterin International, Inc. | 2009-09-11 |