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Orthofix Srl recalls ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18
Recalled November 20, 2019 · FDA recall Z-0386-2020 · Orthofix Srl
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. · FDA Class II
Units
N/A
Sold at
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
Description
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.
Product
ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
Manufacturer(s)
Orthofix Srl
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →