PERLA Cannulated Fenestrated Polyaxial Screw Recall: Incorrect Labeling Risk

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Contact the company & request your remedy

Recalling firmSPINEART SAChemin Du Pre-Fleuri 3, N/A · Plan-Les-Ouates, N/A N/A

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✎ GovInfoNow plain-language explainer

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.

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
Category
Medical device

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

Is this recall affecting my surgery?

The recall applies to medical screws used in spinal procedures. If you have the specific model and lot code, contact your surgeon to discuss potential risks.

How can I tell if I have the recalled screws?

Look for the model number MPF-PS 55 45-S and lot code 8-4266 on the packaging or documentation.

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.

Take action

Contact PERLA

We’ve drafted a message you can send PERLA to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2280-2025 — PERLA PERLA

Hello,

I own a PERLA that is covered by recall Z-2280-2025 from PERLA.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

SPINEART SA recalls Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S

Lower-risk recall