Z-0401-2020 Class II Terminated
FDA device recall Z-0401-2020 was initiated by Orthofix Srl on Sep 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… The recall status is terminated (terminated Feb 1, 2022).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2019
- Initiation Date
- Sep 27, 2018
- Termination Date
- Feb 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
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 #: B1200695, B1224714
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0401-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026