Z-2555-2025Class II

PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

Name: Z-2555-2025 PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Creator: Orthofix U.S. LLC
Published: 2025-06-24
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2025-06-24 / Open, Classified / root cause: labeling and UDI

FDA source

Orthofix U.S. LLC began a recall of PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP on 2025-06-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2555-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-24
Posted: 2025-09-11
Recalling firm: Orthofix SRL
Product: PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 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 [email protected]
Quantity in commerce: 3
Distribution: US Nationwide distribution in the states of CO, CA.
Product codes and lots: UDI-DI: 18257200161010, Lots: 001, 002, and 003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2555-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2555-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-11

Product code MAX

K240749Class IIPILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc. / cleared 2024-05-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)