Recall Z-0388-2020
Orthofix Srl · initiated September 27, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
Codes / lots: Lot # B1201157, B1203789, B1226060
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.
FDA-determined cause: Device Design
Action taken
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 the contact details on the attached form. 4. Subsequent Distribution: If your firm has provided or sold the affected products to other users, please provide a list of those users to the undersigned and forward this notification to them to assure prompt action. 5. Product Return Instructions: To return the devices affected by this action, please follow these instructions: A - Check your inventory for the devices affected by this action; B - Complete the attached Acknowledgement Form with the quantity you are returning; C - Contact Orthofix Customer Service at (800) 266-3349 for return instructions and replacement information
Details
- Recall number
- Z-0388-2020
- Initiated
- September 27, 2018
- Terminated
- February 1, 2022
- Product code
- JDW – Pin, Fixation, Threaded
- 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
- Recalling firm
- Orthofix Srl, Veronaverona
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0373-2020 Class II | ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0374-2020 Class II | ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0375-2020 Class II | ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0376-2020 Class II | ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0377-2020 Class II | ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0378-2020 Class II | ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0379-2020 Class II | ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0380-2020 Class II | ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED-…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0381-2020 Class II | ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0382-2020 Class II | ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED-…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0383-2020 Class II | ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0384-2020 Class II | ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0385-2020 Class II | ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0386-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM-…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0387-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0389-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0390-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0391-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0392-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0393-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0394-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0395-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0396-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0397-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0398-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0399-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0400-2020 Class II | ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0401-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0402-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |
| Z-0403-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | 09/27/2018Terminated |