Z-0374-2020 Class II Terminated
FDA device recall Z-0374-2020 was initiated by Orthofix Srl on September 27, 2018 and is designated Class II. 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 perf… The recall status is terminated (terminated February 1, 2022). Affected quantity: N/A.
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
Reason for Recall
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