CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

Orthofix Pillar SA Ti Spacer System Intervertebral Body recalled

Orthofix U.S is recalling Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, distributed nationwide in the US. The recall was initiated on 20 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(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.

Quantity recalled20

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1432-2025
FDA event ID: 96351
Recalling firm: Orthofix U.S, Lewisville, TX
Classification: Class II
Status: Ongoing
Recall initiated: 20 Feb 2025
FDA classified: 21 Mar 2025
Reported: 2 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Labeling Errors
Device type: Spinal Implants

Timeline

20 Feb 2025	Recall initiated by company
21 Mar 2025	Classified by FDA	+29 days
2 Apr 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the states of California, Colorado, and Missouri.

Nationwide California Colorado Missouri

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

(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.

Where was it sold?

US Nationwide distribution in the states of California, Colorado, and Missouri.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Orthofix U.S

All 13

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	Orthofix Minirail, Short, Lengthener recalled by Orthofix U.S	Orthofix U.S	Labeling Errors	22 states
22 Jul 2026Device	CLASS II	Orthofix Minirail, Articulated, Fixator, Vertical Axis recalled	Orthofix U.S	Labeling Errors	22 states
22 Jul 2026Device	CLASS II	Orthofix Articulated Minirail Fixator Horizontal Axis recalled	Orthofix U.S	Labeling Errors	22 states
22 Jul 2026Device	CLASS II	Orthofix Minirail, Standard Lengthener recalled by Orthofix U.S	Orthofix U.S	Labeling Errors	22 states
17 Dec 2025Device	CLASS III	Forza" PTC Spacer System recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide

Other Spinal Implants recalls

All 1,159

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide