BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle with the use of the Multi-Axial Screw Driver. The component is used within the Firebird Spinal Fixation System. The screw is cannulated and available modular (77-7630, pre-assembled with screw head) or non-modular (77-8630, without screw head). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II. Intended for use when implanted over a guide wire for additional accuracy with reference to the pedicle.
This recall has been terminated (originally issued March 16, 2011).
- Company
- Orthofix, Inc
- Recall Initiated
- October 22, 2010
- Posted
- March 16, 2011
- Terminated
- May 31, 2011
- Recall Number
- Z-1674-2011
- Quantity
- 27 (19 of 77-7630) (8 of 77-8630)
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
Reason for Recall
There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.
Distribution
Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.
Lot / Code Info
Catalog #'s: 77-7630 and 77-8630. 510(k) Information: K081684 (Blackstone Medical Inc.). Lot #: R01. UPC's: M3327776301G and M3327786301H.
Root Cause
Other
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.