Orthofix U.S recalls

Orthofix U.S has 13 recalls on record with the FDA and USDA, the earliest in 2025 and the latest reported on 22 Jul 2026. 13 are still ongoing. 11 were reported in the last 12 months.

Total recalls13since 2025

Last 12 months11reported

Class I00% of total

Ongoing13latest 22 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 0 0Aug 1 0 1Nov 6 0 0Feb 0 0 0May 0 4 0Aug 0 0

Severity split

Class I 0 0%Class II 7 54%Class III 6 46%

Why orthofix u.s is recalled

Other Reasons862%
Labeling Errors538%

Product types

By year

2026431%
2025969%

Ongoing orthofix u.s recalls

13 active

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
17 Dec 2025Device	CLASS III	Pillar" SA PTC Spacer System recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide

All orthofix u.s recalls, newest first

13 total

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
17 Dec 2025Device	CLASS III	Pillar" SA PTC Spacer System recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide
17 Dec 2025Device	CLASS III	Firebird" SI Fusion System recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide
17 Dec 2025Device	CLASS III	Construx" Mini PTC Spacer System recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide
17 Dec 2025Device	CLASS III	Construx" Mini Ti Spacer System recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide
17 Dec 2025Device	CLASS III	Forza" Ti Spacer System recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide
19 Nov 2025Device	CLASS II	Virata Preassembled Polyaxial Screw, utilized recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide
17 Sep 2025Device	CLASS II	Pillar SA Ti, Sterile (W) (D) (H), 20-degrees recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide
2 Apr 2025Device	CLASS II	Orthofix Pillar SA Ti Spacer System Intervertebral Body recalled	Orthofix U.S	Labeling Errors	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.