Recall Z-0395-2020 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
| Date | Sep 27, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | On 10/01/2018, Orthofix provided distributor, doctors, and hospitals a urgent medical device recall notification via FedEx overnight carrier . The letter asked consignees to take the following actions: 1. Immediately cease any further distribution of the affected devices; 2. Notify hospitals, surgeons and others to whom you may have distributed affected devices that such devices cannot be used and must be returned to Orthofix according to the instructions below; 3. Complete the Acknowledgement Form indicating that you have received this notification. It should be returned by email or fax to |
| 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, Be |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113770 | ORTHOFIX GALAXY FIXATION SYSTEM Orthofix Srl, Sep 4, 2012 |