BLACKSTONE Medical Inc. Firebird Spinal Fixation System… recallZ-1674-2011 · Orthofix Inc · initiated Oct 22, 2010
Terminated All recalls posted in March 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1674-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 22, 2010
- Posted by the FDA
- Mar 16, 2011
- Recalling firm
- Orthofix Inc
- Quantity
- 27 (19 of 77-7630) (8 of 77-8630)
- Product code
- NKB
- FDA submissions
- K081684
- Distribution
- Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.
Product description
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.
Code information (models, lots, serial numbers)
Catalog #'s: 77-7630 and 77-8630. 510(k) Information: K081684 (Blackstone Medical Inc.). Lot #: R01. UPC's: M3327776301G and M3327786301H.
Other devices under the same FDA submission
3 devices cleared under K081684 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FIREBIRD 44-2001Orthofix US LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- FIREBIRD 44-2101Orthofix US LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- FIREBIRD 77-8645Orthofix US LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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