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Lower risk Medical device recall · FDA · Published May 19, 2025

Limacorporate PRIMA 4MM Eccentric Adaptor Recall: Missing Laser Marking Risk

Limacorporate recalls sterile PRIMA 4MM eccentric adaptors with missing black laser markings that could cause misalignment during medical procedures.

🇺🇸 FDA recall #Z-2025-2025Medical deviceLimacorpor: S.p.A ›
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Recalling firmLimacorporate S.p.AVia Nazionale 52, Di San Daniele · San Daniele Del Friuli, Italy
✎ GovInfoNow plain-language explainer

What happened, in plain English

Limacorporate is recalling sterile PRIMA 4MM eccentric adaptors that may have missing black laser markings. This could lead to improper alignment during medical procedures if the adaptor is used without the marking. Read more at govinfonow.com/recall/52256-limacorporate-prima-4mm-eccentric-adaptor-recall-missing-laser-marking-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52256-limacorporate-prima-4mm-eccentric-adaptor-recall-missing-laser-marking-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2025-2025

Cite this page

“Limacorporate PRIMA 4MM Eccentric Adaptor Recall: Missing Laser Marking Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52256-limacorporate-prima-4mm-eccentric-adaptor-recall-missing-laser-marking-risk. Based on FDA recall #Z-2025-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2025-2025%22&limit=1).

Why it’s dangerous

The adaptor may have missing black laser markings that are supposed to identify its position. Without this marking, the adaptor might not align correctly during medical procedures, potentially causing errors in surgical applications.

Who’s affected

Medical professionals using the PRIMA 4MM eccentric adaptors for surgical procedures are most at risk if the laser marking is missing. Patients receiving procedures with these adaptors could be affected.

How to tell if you have this one

Check for the black laser marking on the PRIMA 4MM eccentric adaptor. The product has a lot number 2421400 and UDI: 08033390201834. This item was sold with the reference number 1367.15.704.

  • Brand
    Limacorpor: S.p.A
  • Category
    Medical device
FDA recall event · 2 products

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
    Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
Recall numberProduct, codes & lotsQuantity
Z-2024-2025PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile; Lot number 2416658/UDI: 0803339020182719 units
Z-2025-2025PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile; Lot number 2421400/UDI: 080333902018349 units
Based on the official FDA remedy

What to do — step by step

  1. Check for Laser Marking

    Look for the black laser marking on the adaptor to confirm it's not missing.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 6 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Mississippi, New York, South Carolina, Texas, Virginia.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: May 19, 202512. FDA classified it Class II: Jun 25, 202523. Published in FDA’s Enforcement Report: Jul 2, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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-2025-2025 (May 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2025-2025 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA