PERLA Cannulated Fenestrated Polyaxial Screw Recall: Incorrect Labeling Risk
SPINEART SA recalls PERLA cannulated fenestrated polyaxial screws (model MPF-PS 5:55 45-S) due to potential incorrect labeling. Affected units may have safety risks if mislabeled.
Lower-risk recall
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Contact the company
What happened, in plain English
SPINEART SA is recalling PERLA cannulated fenestrated polyaxial screws (model MPF-PS 55 45-S) because they may be incorrectly labeled. This could lead to safety issues if the screws are used in medical procedures without proper identification. Read more at govinfonow.com/recall/51924-perla-cannulated-fenestrated-polyaxial-screw-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51924-perla-cannulated-fenestrated-polyaxial-screw-recall-incorrect-labeling-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2280-2025
Cite this page
“PERLA Cannulated Fenestrated Polyaxial Screw Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51924-perla-cannulated-fenestrated-polyaxial-screw-recall-incorrect-labeling-risk. Based on FDA recall #Z-2280-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2280-2025%22&limit=1).
Why it’s dangerous
Incorrect labeling could lead to using the wrong screw type during spinal surgery. This might cause improper fixation or complications if the screws are not correctly identified.
Who’s affected
Medical professionals who use these screws for spinal surgery are most at risk. Patients receiving these screws during procedures may also be affected if mislabeled.
How to tell if you have this one
Check for the model number MPF-PS 55 45-S on the screw packaging. The lot code 8-4266 is also associated with this specific batch.
- Brand
PERLA- Product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of Florida , Kentucky, California.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2279-2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No; Lot Code: Lot number 8-4528 GTIN 07640305160561 | 16 units |
| Z-2280-2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW; Lot Code: Lot number 8-4266 GTIN 07640305160493 | 0 |
What to do — step by step
Check Labeling
Verify the model number and lot code on the screw packaging to confirm it is not the recalled model MPF-PS 55 45-S with lot code 8-4266.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution in the states of Florida , Kentucky, California.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Kentucky.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these screws?
The recall does not require immediate removal. Check the labeling to confirm if you have the recalled model before taking any action.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2280-2025 (June 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2280-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.