CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report

Pillar SA Ti, Sterile (W) (D) (H), 20-degrees recalled by Orthofix U.S

Orthofix U.S is recalling Pillar SA Ti, Sterile (W) (D) (H), 20-degrees, distributed nationwide in the US. The recall was initiated on 24 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 18257200161010, Lots: 001, 002, and 003

Quantity recalled3

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-2555-2025
FDA event ID: 97265
Recalling firm: Orthofix U.S, Lewisville, TX
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jun 2025
FDA classified: 11 Sep 2025
Reported: 17 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Jun 2025	Recall initiated by company
11 Sep 2025	Classified by FDA	+79 days
17 Sep 2025	Published in enforcement report	+6 days

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

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of CO, CA.

Nationwide California Colorado

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 18257200161010, Lots: 001, 002, and 003

Where was it sold?

US Nationwide distribution in the states of CO, CA.

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 Other Medical Devices recalls

All 13,884

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Palacos R pro recalled by Heraeus Medical GmbH (Dental	Heraeus Medical GmbH (Dental Division)	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled	Percussionaire	Other	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire	Percussionaire	Other	Nationwide