FDA Medical Device Recalls (openFDA)
Orthofix, Inc: ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
- Recall number
- Z-1749-2015
- Recalling firm
- Orthofix, Inc
- Product
- ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
- Status
- Terminated
- Initiated
- 2015-05-18
- Posted
- 2015-06-10
- Terminated
- 2015-10-30
- Reason
- The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.
- Root cause
- Unknown/Undetermined by firm
- Action
- Orthofix sent an Urgent Medical Device Recall Notification letter dated May 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Affected customers were instructed to inspect their inventory, and identify and remove the recalled product to send back to Orthofix. The distributors are also instructed to provide recall notification to hospitals, surgeons, or other distributors that they have further distributed affected product to. Contact your local Orthofix representative or Orthofix customer service representative at 888-298-5700 for return instructions and shipment information.
- Quantity
- 45 units
- Distribution
- US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.
- Lot, serial or model codes
- Lot Number S29
- 510(k) numbers
- ["K130932"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 2183449
- Firm city
- Lewisville
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28