Z-1608-2011

ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot...

Name: Z-1608-2011 ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot...
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 ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with... on 2010-10-22. The reason FDA records is "There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1608-2011
Status: Terminated
Initiated: 2010-10-22
Posted: 2011-03-08
Terminated: 2011-04-25
Recalling firm: Orthofix SRL
Product: ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body after assembly of the construct. The Anti-Splay Cap is a stainless steel machined instrument. The instrument is used within the Firebird Reduction Kit (Domestic, 44-9050) and the ICON Reduction Kit (International, 68-0010). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.
FDA root cause: Other
Action: The firm, Orthofix, sent an "URGENT: PRODUCT RECALL" letter dated October 22, 2010 to all customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to: 1) identify and remove the affected product 2) complete the enclosed Tracking and Verification Form via fax to: Orthofix Inc. at 214-937-2764, and 3) contact their Account Services Representative at 1-888-298-5700 and obtain a return authorization number to return product to Orthofix, Inc. The letter also states that Orthofix Inc., will provide replacement Anti-Splay Caps via priority delivery. If you have any questions regarding the removal and return of this product to Orthofix Inc., please contact your Account Service Representative at 1-888-298-5700. Should you have any other questions or concerns, please contact the Director of Regulatory Affairs at 214-937-2061 or by email: [email protected].
Quantity in commerce: 166 Units
Distribution: Nationwide distribution: USA including states of: CA, CO, FL, LA , MD, MI, MO, NJ, NY, OH, TN, VA, and WA.
Product codes and lots: Part #68-0111, Lot #16518-LC18.

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)