Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall The MobiC Cervical Disc Prosthesis (MobiC; MobiC 14mm Distraction Screw

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall The MobiC Cervical Disc Prosthesis (MobiC; MobiC 14mm Distraction Screw see related information
Date Initiated by Firm April 01, 2019
Create Date June 19, 2019
Recall Status1 Terminated 3 on May 11, 2020
Recall Number Z-1845-2019
Recall Event ID 83004
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement.
Item Number: 0024-LDR
TEDAN SURGICAL INNOVATIONS LLC
DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750

Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery
Code Information Lot Number: 2017102450
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact SAME
574-372-1687
Manufacturer Reason
for Recall		 Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm length screw
FDA Determined
Cause 2		 Labeling mix-ups
Action Zimmer issued letter notification dated 4/1/19 via email and FedX identifying the issue, health risk, and action to take: 1. Review this notification and ensure that affected team members are aware of the contents. 2.Immediately locate and quarantine affected product in your inventory.3.Immediately return all affected product from your distributorship and from affected hospitals within your territory. Complete Attachment 1  Inventory Return Certification Form4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-447-3625 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 313 units
Distribution US Nationwide distribution.
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.
-
-