Orthofix U.S. LLC recalls
Every recall we track for Orthofix U.S. LLC — 13 in all, from 2025–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Orthofix U.S. LLC peaked in 2025 (9); 13 since 2017. 8% rated “stop using now”.
All FDA recall records for Orthofix U.S. LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 8 | 0 | 9 |
| 2026 (to date) | 0 | 0 | 4 | 0 | 4 |
Most common reasons for Orthofix U.S. LLC recalls
What to do if you have a recalled Orthofix U.S. LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Orthofix U.S. LLC recalls
5 shown- Lower riskMedical device
Orthofix U.S. LLC recalls Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Orthofix recalls MINIRAIL Standard Lengthener Model M101 due to mislabeling risks incorrect use. Check your device's model number against the recall list.
OrthofixJun 10, 2026 - Lower riskMedical device
Orthofix U.S. LLC recalls Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti
Orthofix U.S. LLC recalls Forza Ti Spacer Systems with model numbers 38-2006SP to 38-3914SP due to inconsistent labeling claims. No remedy is specified in the recall notice.
Forza TiNov 3, 2025 - Stop using nowMedical device
Orthofix U.S. LLC recalls Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:
Orthofix recalls 25 specific sizes of Virata Preassembled Polyaxial Screws used in spinal fixation systems due to not meeting performance standards. Affected items include 5.5mm and 6.5mm screws with various lengths and lot numbers.
OrthofixSep 19, 2025 - Lower riskMedical device
Orthofix U.S. LLC recalls PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Orthofix recalls specific 37mm PILLAR SA Ti spinal fusion devices due to incorrect label width measurements. This labeling error may cause improper surgical use. Affected devices have UDI-DI: 18257200161010 and lots 001-003.
OrthofixJun 24, 2025 - Lower riskMedical device
Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:
Orthofix recalls three spinal implant models due to mislabeled anterior height (10mm vs 10.5mm). This could affect spinal fusion surgery accuracy. Contact Orthofix for details.
OrthofixFeb 20, 2025
Orthofix U.S. LLC recall questions
How many recalls has Orthofix U.S. LLC had?
13 recalls from Orthofix U.S. LLC are on record with U.S. safety agencies, from 2025–2026.
What is the most recent Orthofix U.S. LLC recall?
Orthofix U.S. LLC recalls Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device, dated Jun 10, 2026. Every Orthofix U.S. LLC recall is listed on this page, newest first.
Why are Orthofix U.S. LLC products recalled?
The most common reasons on record: Labeling contains claims that are not consistently present. (6).
What should I do if I have a recalled Orthofix U.S. LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Orthofix U.S. LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.