Z-1432-2025Class II

Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium...

Name: Z-1432-2025 Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium...
Creator: Orthofix U.S. LLC
Published: 2025-02-20
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2025-02-20 / Open, Classified / root cause: labeling and UDI

FDA source

Orthofix U.S. LLC began a recall of Orthofix 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... on 2025-02-20. FDA classified it as Class II and gives the reason as "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". 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-1432-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-20
Posted: 2025-03-21
Recalling firm: Orthofix SRL
Product: Orthofix 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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 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 [email protected]
Quantity in commerce: 20
Distribution: US Nationwide distribution in the states of California, Colorado, and Missouri.
Product codes and lots: (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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1432-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1432-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21

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)