ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
Reported: November 20, 2019 Initiated: September 27, 2018 #Z-0400-2020
Product Description
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
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.
Details
- Recalling Firm
- Orthofix Srl
- Units Affected
- N/A
- Distribution
- 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
- Location
- Veronaverona, N/A
Frequently Asked Questions
What product was recalled? ▼
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922. Recalled by Orthofix Srl. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2019. Severity: Moderate. Recall number: Z-0400-2020.
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