CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report

Orthofix Minirail, Standard Lengthener recalled by Orthofix U.S

Orthofix U.S is recalling Orthofix Minirail, Standard Lengthener, distributed in 22 states. The recall was initiated on 10 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots; GTIN# 18032568866636;

Quantity recalled48 units

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-2729-2026
FDA event ID: 99225
Recalling firm: Orthofix U.S, Lewisville, TX
Classification: Class II
Status: Ongoing
Recall initiated: 10 Jun 2026
FDA classified: 14 Jul 2026
Reported: 22 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Hip & Knee Implants

Timeline

10 Jun 2026	Recall initiated by company
14 Jul 2026	Classified by FDA	+34 days
22 Jul 2026	Published in enforcement report	+8 days

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

Reason for recall

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Product as listed by the FDA

Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

Where it was distributed

US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None

Arizona California Colorado Connecticut Florida Georgia Illinois Louisiana Maryland Michigan Missouri Mississippi Montana North Carolina New York South Carolina South Dakota Texas Utah Virginia

Questions about this recall

Why was it recalled?

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Which lots are affected?

All Lots; GTIN# 18032568866636;

Where was it sold?

US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None

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.

Other products in this recall event

3 other products · FDA event 99225

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026	CLASS II	Orthofix Articulated Minirail Fixator Horizontal Axis recalled	Orthofix U.S	Labeling Errors	22 states
22 Jul 2026	CLASS II	Orthofix Minirail, Articulated, Fixator, Vertical Axis recalled	Orthofix U.S	Labeling Errors	22 states
22 Jul 2026	CLASS II	Orthofix Minirail, Short, Lengthener recalled by Orthofix U.S	Orthofix U.S	Labeling Errors	22 states

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
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

Other Hip & Knee Implants recalls

All 3,110

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled	New York Embroidery Studio	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide