Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PILLAR SA Ti Spacer System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall PILLAR SA Ti Spacer Systemsee related information
Date Initiated by FirmFebruary 20, 2025
Date PostedMarch 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1432-2025
Recall Event ID 96351
510(K)NumberK240749 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductOrthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.
Code Information (1) REF 82-3300SP - Lot Number 001, UDI 18257200160426; (2) REF 82-3700SP - Lot Number 001, UDI 18257200160884; and (3) REF 82-4000SP - Lot Number 001, UDI 18257200161270.
Recalling Firm/
Manufacturer		 Orthofix U.S. LLC
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information ContactOrthofix Complaints
214-937-2000
Manufacturer Reason
for Recall		The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 2/20/2025, correction notices were emailed to distributors who were informed of the following: This notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Attach this notice to the inventory in your possession, if possible. Should you have any questions regarding this matter, please contact the firm at madison.ebel@seaspine.com
Quantity in Commerce20
DistributionUS Nationwide distribution in the states of California, Colorado, and Missouri.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MAX
-
-