What should I do if I have a Forza Ti Spacer System?

Stop using the Forza Ti Spacer System immediately and contact Orthofix U.S. LLC or your healthcare provider for further instructions.

Are there any reported injuries related to this recall?

As of the recall date, there have been no reported injuries or adverse events linked to the labeling issues.

How can I get a refund for my recalled product?

Follow the recall instructions provided by Orthofix. Contact them directly for specific refund procedures.

What is the risk associated with the labeling issue?

The inconsistent labeling claims can mislead users about the product's use, potentially compromising patient health.

Where can I find the model numbers for the recalled products?

Model numbers can be found on the product packaging or the device itself. Refer to the list provided in the recall announcement.

How can I stay updated on recalls affecting medical devices?

You can check the FDA website regularly for updates on medical device recalls and safety alerts.

Is it safe to continue using my Forza Ti Spacer System if it looks fine?

No, it is not safe to continue using the device due to the recall. Follow the instructions to ensure your safety.

What happens if I don’t return the recalled product?

Not returning the recalled product could pose a risk to your health if the labeling misleads you about its use.

Can I sell my recalled Forza Ti Spacer System?

No, it is illegal to sell or distribute a recalled product. It is important to return it according to the recall instructions.

What is the recommended method for disposing of the recalled product?

Follow local regulations for medical waste disposal. Contact your healthcare provider for guidance.

HIGHNovember 3, 2025

Orthofix Recalls Ti Spacer System Due to Labeling Issues

Orthofix U.S. LLC recalled 14,201 units of the Forza Ti Spacer System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Patients and healthcare providers should stop using the product immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date: November 3, 2025
Hazard Level: HIGH
Brand: Orthofix U.S.
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

Labeling contains claims that are not consistently present.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: E-Mail

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Product Details

The recalled Forza Ti Spacer System includes multiple models with catalog numbers ranging from 38-2006SP to 38-3414SP. The products were distributed worldwide, including across all U.S. states and several countries like Australia, Germany, and Canada. The quantity recalled is 14,201 units.

The Hazard

The recall is due to labeling claims that are not consistently present, which poses a risk to users. Misleading information on medical devices can lead to improper use or reliance on the product, potentially compromising patient health.

What to Do

Stop using the Forza Ti Spacer System immediately. Contact Orthofix U.S. LLC or your healthcare provider for further instructions and follow the recall guidance provided. Refund processes may vary.

Contact Information

For more information, contact Orthofix U.S. LLC at [insert contact number] or visit their website for detailed recall instructions.

Key Facts

Recall date: November 3, 2025
Reported incidents: None
Quantity recalled: 14,201 units
Distributed worldwide
Labeling inconsistencies identified

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

6/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeTi Spacer System

Product Details

Brand

Orthofix U.S.

Categories

Health & Personal Care Medical Devices

Model Numbers

Lot Code: All Lot Codes/ UDI: 38-2006SP 18257200151769 38-2007SP 18257200151776 38-2008SP 18257200151783 38-2009SP 18257200151790 38-2010SP 18257200151806 38-2011SP 18257200151813 38-2012SP 18257200151820 38-2013SP 18257200151837 38-2014SP 18257200151844 38-2106SP 18257200151875 38-2107SP 18257200151882 38-2108SP 18257200151899 38-2109SP 18257200151905 38-2110SP 18257200151912 38-2111SP 18257200151929 38-2112SP 18257200151936 38-2113SP 18257200151943 38-2114SP 18257200151950 38-2206SP 18257200151981 38-2207SP 18257200151998 38-2208SP 18257200152001 38-2209SP 18257200152018 38-2210SP 18257200152025 38-2211SP 18257200152032 38-2212SP 18257200152049 38-2213SP 18257200152056 38-2214SP 18257200152063 38-2309SP 18257200152094 38-2310SP 18257200152100 38-2311SP 18257200152117 38-2312SP 18257200152124 38-2313SP 18257200152131 38-2314SP 18257200152148 38-2508SP 18257200152360 38-2509SP 18257200152377 38-2510SP 18257200152384 38-2511SP 18257200152391 38-2512SP 18257200152407 38-2513SP 18257200152414 38-2514SP 18257200152421 38-3206SP 18257200152179 38-3207SP 18257200152186 38-3208SP 18257200152193 38-3209SP 18257200152209 38-3210SP 18257200152216 38-3211SP 18257200152223 38-3212SP 18257200152230 38-3213SP 18257200152247 38-3214SP 18257200152254 38-3409SP 18257200152285 38-3410SP 18257200152292 38-3411SP 18257200152308 38-3412SP 18257200152315 38-3413SP 18257200152322 38-3414SP 18257200152339 38-3506SP 18257200152759 38-3507SP 18257200152766 38-3508SP 18257200152773 38-3509SP 18257200152780 38-3510SP 18257200152797 38-3511SP 18257200152803 38-3512SP 18257200152810 38-3513SP 18257200152827 38-3514SP 18257200152834 38-3608SP 18257200152865 38-3609SP 18257200152872 38-3610SP 18257200152889 38-3611SP 18257200152896 38-3612SP 18257200152902 38-3613SP 18257200152919 38-3614SP 18257200152926 38-3706SP 18257200152957 38-3707SP 18257200152964 38-3708SP 18257200152971 38-3709SP 18257200152988 38-3710SP 18257200152995 38-3711SP 18257200153008 38-3712SP 18257200153015 38-3713SP 18257200153022 38-3714SP 18257200153039 38-3808SP 18257200153060 38-3809SP 18257200153077 38-3810SP 18257200153084 38-3811SP 18257200153091 38-3812SP 18257200153107 38-3813SP 18257200153114 38-3814SP 18257200153121 38-3908SP 18257200153152 38-3909SP 18257200153169 38-3910SP 18257200153176 38-3911SP 18257200153183 38-3912SP 18257200153190 38-3913SP 18257200153206 38-3914SP 18257200153213

Affected States

ALL

Report Date

December 17, 2025

Source Agency

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Apr 2, 2027

Audi

A loss