OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
FDA device recall Z-1138-2013 · posted 2013-04-17 · Terminated
Recall details
- Recalling firm
- Bacterin International, Inc.
- Reason for recall
- The firm's retesting procedure was not validated.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MBP
- Quantity affected
- 165
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-02-21
- Date posted
- 2013-04-17
- Date terminated
- 2013-07-01
- Location
- Belgrade, MT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (K091321) | Bacterin International, Inc. | 2009-09-11 |