Reported Nov 20, 2019 · Terminated
ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01)…
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: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY
- UDI(01) 18033509855948
- Lot codes and dates
Lot # B1207286B1207428B1211384B1215263 *Not marketed in US
- 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.
Want the full recall guide?
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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