Reported Nov 20, 2019 · Terminated

ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non…

Orthofix Srl

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: Orthofix Srl · Via Delle Nazioni 9 O 73 · Veronaverona, N/A · N/A

Is this the product you have?

  • ORTHOFIX Catalogue Numberref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile
  • UDI(01)18032568039603
Lot codes and dates
    • Lot # B1200713
    • 289813
    • 289813
    • 300237
    • 300237
    • 300238
    • 289813
    • 273342
Amount recalled
N/A

This recall covers 31 products

The agency filed one notice per product. You are reading one of them; the other 30 are below.

18 more are in the archive.

Where it was sold

Why it was recalled

As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 1, 2022 · Data as of Sep 19, 6:50 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.