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Use caution Medical device recall · FDA · Published April 26, 2021

Meta C.G.M. Spa Oral Surgery Devices May Not Be Sterile - Recall

Meta C.G.M. Spa recalls specific oral surgery devices (REF 4049 MICROSS, CE0123, STERILE EO) due to potential sterility issues. Devices may not have been adequately sterilized, posing risks during use.

🇺🇸 FDA recall #Z-1777-2021Medical deviceMeta C.G.M. Spa ›
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Contact the company

Recalling firmMeta C.G.M. SpaVia Modena 22-24 · Correggio, Italy
✎ GovInfoNow plain-language explainer

What happened, in plain English

Meta C.G.M. Spa is recalling certain oral surgery devices that may not have been properly sterilized. This could lead to infection or other complications if used in procedures requiring sterile equipment. Read more at govinfonow.com/recall/62705-meta-c-g-m-spa-oral-surgery-devices-may-not.

Source Summary by GovInfoNow · govinfonow.com/recall/62705-meta-c-g-m-spa-oral-surgery-devices-may-not · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1777-2021

Cite this page

“Meta C.G.M. Spa Oral Surgery Devices May Not Be Sterile - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62705-meta-c-g-m-spa-oral-surgery-devices-may-not. Based on FDA recall #Z-1777-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1777-2021%22&limit=1).

Why it’s dangerous

The devices are labeled as sterile but may not have been adequately sterilized. This could result in contamination during oral surgery procedures, increasing the risk of infection or complications.

Who’s affected

Oral surgery patients and healthcare providers who use the recalled devices. Those with the specific lot numbers listed are most at risk.

How to tell if you have this one

Check for the lot numbers: 2-01121, 23-28920, 21-26520, 18-24819, 24-29118, 21-24818, 13-12818, 26-33118. The devices are used in oral surgery and have the model REF 4049 MICROSS, CE0123, STERILE EO.

  • Brand
    Meta C.G.M. Spa
  • Category
    Medical device
FDA recall event · 4 products

All 4 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
    Terminated
  • Distribution
    Distribution in US states of Texas and Florida
Recall numberProduct, codes & lotsQuantity
Z-1776-2021REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.; Lot number: 10-10719, 25-31118, 23-27018, 16-17118, 15-17018, 2-01521, 23-26620, 23-26820, 17-17920, 7-06519, 17-19818, 17-19818, and 13-128188,370 units
Z-1777-2021REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.; Lot number: 2-01121, 23-28920, 21-26520, 18-24819, 24-29118, 21-24818, 13-12818, 26-331181,692
Z-1778-2021REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.; Lot number: 26-33118 and 17-19818150 units
Z-1779-2021REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.; Lot number: 1-3531927 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Lot Number

    Look for the lot numbers listed: 2-01121, 23-28920, 21-26520, 18-24819, 24-29118, 21-24818, 13-12818, 26-33118.

Where it went and when

Where it was distributed

Distributed in Florida and Texas.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distribution in US states of Texas and Florida” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Texas.

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

1. Firm started the recall: Apr 26, 202112. FDA classified it Class II: Jun 2, 202123. Published in FDA’s Enforcement Report: Jun 9, 202134. FDA terminated the recall: Sep 12, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

What should I do if I have one of these devices?

Check the lot number against the list provided. If it matches, stop using it and contact Meta C.G.M. Spa for further instructions.

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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-1777-2021 (April 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1777-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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