PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Summary
The FDA issued a Class II for PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713S by Orthofix U.S. LLC. Reason: 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 a.
Details
Source
Device Recall
External ID
Z-2555-2025
Action Date
2025-09-17
Status
Ongoing
Category
device
Product Description
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Lot/Code Info: UDI-DI: 18257200161010, Lots: 001, 002, and 003
Quantity Affected: 3
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.
Distribution
US Nationwide distribution in the states of CO, CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-24
Company
Lewisville, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Orthofix U.S. LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Orthofix U.S. LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orthofix U.S. LLC have FDA actions?
Orthofix U.S. LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2555-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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