FDAFDA · Food and drugs·Recall number Z-0390-2020
ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
Published November 20, 2019 · Recall initiated: September 27, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthofix Srl
- Distributor
- US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
- Lot
- Lot # B1207286, B1207428, B1211384, B1215263 *Not marketed in US
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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