Z-0378-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- September 27, 2018
- Termination Date
- February 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
Reason for Recall
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.
Distribution Pattern
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
Code Information
Lot # B1200720, 289819, 273352