Z-1674-2011

BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated...

Name: Z-1674-2011 BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated...
Creator: Orthofix Inc
Published: 2010-10-22
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2010-10-22 / Terminated

FDA source

Orthofix Inc began a recall of BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation... on 2010-10-22. The reason FDA records is "There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1674-2011
Status: Terminated
Initiated: 2010-10-22
Posted: 2011-03-16
Terminated: 2011-05-31
Recalling firm: Orthofix SRL
Product: 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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.
FDA root cause: Other
Action: 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.
Quantity in commerce: 27 (19 of 77-7630) (8 of 77-8630)
Distribution: Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.
Product codes and lots: Catalog #'s: 77-7630 and 77-8630. 510(k) Information: K081684 (Blackstone Medical Inc.). Lot #: R01. UPC's: M3327776301G and M3327786301H.

Product code NKB

K081684Class IIBlackstone Pedicle Screw SystemBlackstone Medical, Inc. / cleared 2008-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)