SPINEART SA 2025-08-20 Health serious FDA
Health · FDA · Recall #FDA-Z-2280-2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW … Recall
Issued August 20, 2025 · SPINEART SA
In August 2025, SPINEART SA recalled the Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Cannulated fenestrated polyaxial screws may be incorrectly labeled
What you should do
- 1 Stop using Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SPINEART SA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SPINEART SA
- Category
- Health
- Recall date
- August 20, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of Florida , Kentucky, California.
- Recall number
- FDA-Z-2280-2025
- Made in
- Switzerland
- Issuing agency
- FDA
In context
- SPINEART SA has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.