BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Me
FDA device recall Z-1674-2011 · posted 2011-03-16 · Terminated
Recall details
- Recalling firm
- Orthofix Inc
- Reason for recall
- There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.
- Action taken
- Orthofix sent an URGENT: PRODUCT RECALL letter dated October 22, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their accounts immediately and advise them of the recall situation and have them return any affected inventory. For any questions customers were instructed to contact their Account Services Representative at 1-888-298-5700. For questions regarding this recall call 214-937-2061.
- Root cause
- Other
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 27 (19 of 77-7630) (8 of 77-8630)
- Distribution
- Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.
- Date initiated
- 2010-10-22
- Date posted
- 2011-03-16
- Date terminated
- 2011-05-31
- Location
- Lewisville, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLACKSTONE PEDICLE SCREW SYSTEM (K081684) | Blackstone Medical, Inc. | 2008-09-15 |