Recall Z-1138-2013 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Bacterin International, Inc.
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
| Date | Apr 17, 2013 (initiated Feb 21, 2013) |
| Status | Terminated |
| Reason | The firm's retesting procedure was not validated. |
| Root cause | Process control |
| Action | Bacterin sent a Voluntary Product Recall Notification letter via e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are being asked to return any remaining product by obtaining a Return Authorization number from them. Bacterin is also asking customers to return the verification form mailed with the recall letter regardless of whether or not they had any product on hand. For questions contact Bacterin sales representative or Bacterin Customer Service. |
| Quantity | 165 |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091321 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY Bacterin International, Inc., Sep 11, 2009 |