Reported Jun 9, 2021 · Terminated

REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

Meta C.G.M. Spa

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Meta C.G.M. Spa · Via Modena 22-24 · Correggio · N/A

Is this the product you have?

  • REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
Lot codes and dates
  • 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 13-12818
Amount recalled
8,370 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 12, 2024 · Data as of Sep 19, 7:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.