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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHOFIX

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  Class 2 Device Recall ORTHOFIX see related information
Date Initiated by Firm September 27, 2018
Create Date November 14, 2019
Recall Status1 Terminated 3 on February 01, 2022
Recall Number Z-0387-2020
Recall Event ID 84004
510(K)Number K955848  
Product Classification Pin, fixation, threaded - Product Code JDW
Product ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
Code Information Lot # B1207402, B1209817, B1211407, B1212676, B1229618, B1232423, B1233324, B1233663 
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 and Original Applicant = ORTHOFIX, INC.
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