Reported Nov 20, 2019 · Terminated
ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile,…
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 Number
ref 1-1100701DRILL BIT D.48 MM L.280 MM TIN COATED - QUICK CONNECTRX ONLYNon Sterile
- UDI(01)18033509856099
- Lot codes and dates
Lot # B1199835289815289815273344
- 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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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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