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U.S. Department of Health and Human Services

Class 2 Device Recall Pillar SA Ti

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 Class 2 Device Recall Pillar SA Tisee related information
Date Initiated by FirmJune 24, 2025
Date PostedSeptember 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2555-2025
Recall Event ID 97265
510(K)NumberK240749 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductPILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Code Information UDI-DI: 18257200161010, Lots: 001, 002, and 003
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		A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
FDA Determined
Cause 2		Labeling design
ActionOn 6/24/2025, recall notes were emailed to customers who were asked to do the following: 1) Examine your inventory and quarantine any affected product. 2) If implanted, healthcare Providers should determine whether it is necessary to inform the patient, based on clinical judgment and individual circumstances. 3) This notice should be shared with all relevant personnel within your organization and forwarded to any other organization or facility where potentially affected devices may have been transferred. 4) Complete and return the response form to the firm. Should you have any questions regarding this matter, please contact the firm at madison.ebel@seaspine.com
Quantity in Commerce3
DistributionUS Nationwide distribution in the states of CO, CA.
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
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