| Class 2 Device Recall ORTHOFIX | |
Date Initiated by Firm | September 27, 2018 |
Create Date | November 14, 2019 |
Recall Status1 |
Terminated 3 on February 01, 2022 |
Recall Number | Z-0382-2020 |
Recall Event ID |
84004 |
510(K)Number | K955848 |
Product Classification |
Pin, fixation, threaded - Product Code JDW
|
Product | ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075 |
Code Information |
Lot # B1203608, B1210965, B1211752, B1214172,B1218793, 300241,300240,273169 |
Recalling Firm/ Manufacturer |
Orthofix Srl Via Delle Nazioni 9 O 73 Veronaverona Italy
|
Manufacturer 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 2 | 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 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 |
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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JDW
|
|
|
|