Health & Personal Care
HIGH
FDA DEVICE
Orthofix Recalls FORZA PTC Spacer System Over Labeling Issues
Labeling contains claims that are not consistently present.
Orthofix U.S.
Labeling contains
Brand hub
Orthofix U.S. Recalls
7 recalls found for Orthofix U.S.. Check current safety alerts and related brands before using affected products.
- Active recalls
- 7
- Pages
- 1
Health & Personal Care
HIGH
FDA DEVICE
Orthofix Recalls FIREBIRD SI Fusion System Over Labeling Issues
Orthofix U.S. recalled 19,431 units of its FIREBIRD SI Fusion System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Affected models include multiple sizes of FIREBIRD SI Screws, sold worldwide.
Orthofix U.S.
Labeling contains
Health & Personal Care
HIGH
FDA DEVICE
Orthofix Recalls PTC Spacer Systems Over Labeling Issues
Labeling contains claims that are not consistently present.
Orthofix U.S.
Labeling contains
Health & Personal Care
HIGH
FDA DEVICE
Orthofix Recalls Ti Spacer System Due to Labeling Issues
Labeling contains claims that are not consistently present.
Orthofix U.S.
Labeling contains
Health & Personal Care
HIGH
FDA DEVICE
Orthofix Recalls CONSTRUX Mini Ti Spacer System Over Labeling Issues
Orthofix U.S. recalled 40,956 units of the CONSTRUX Mini Ti Spacer System on November 3, 2025. Labeling inconsistencies pose potential risks to patients and healthcare providers. Users should stop using the device immediately and follow recall instructions.
Orthofix U.S.
Labeling contains
Health & Personal Care
HIGH
FDA DEVICE
Orthofix Recalls CONSTRUX Mini PTC Spacer System Due to Labeling Issues
Labeling contains claims that are not consistently present.
Orthofix U.S.
Labeling contains
Health & Personal Care
HIGH
FDA DEVICE
Orthofix Pillar SA Ti Spinal Implant Recalled for Labeling Error (2025)
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.
Orthofix U.S.
A 37
Brand Statistics
Total Recalls
7
Pages
1