Class 2 Device Recall Blackstone Medical Inc. Firebird Spinal Fixation System

• Date Initiated by Firm: October 22, 2010
• Date Posted: March 16, 2011
• Recall Status: Terminated on May 31, 2011
• Recall Number: Z-1674-2011
• Recall Event ID: 57199
• 510(K)Number: K081684
• Product Classification: Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
• 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.
• Code Information: Catalog #'s: 77-7630 and 77-8630. 510(k) Information: K081684 (Blackstone Medical Inc.). Lot #: R01. UPC's: M3327776301G and M3327786301H.
• FEI Number: 2183449
• Recalling Firm/ Manufacturer: Orthofix Inc; 3451 Plano Parkway; Lewisville TX 75056-9453
• Manufacturer Reason for Recall: There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NKB