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 Omni Spine Anterior Cervical Plate System

  • 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 Omni Spine Anterior Cervical Plate System see related information
Date Initiated by Firm November 13, 2017
Create Date December 13, 2017
Recall Status1 Terminated 3 on October 15, 2019
Recall Number Z-0239-2018
Recall Event ID 78592
510(K)Number K092531  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System

The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).
Code Information Part No. CSF-40-12, Lot No. 132635
Recalling Firm/
Manufacturer		 Amendia, Inc dba Spinal Elements
1755 W Oak Pkwy
Marietta GA 30062-2260
For Additional Information Contact Tiffany Teo
770-575-5274
Manufacturer Reason
for Recall		 Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
FDA Determined
Cause 2		 Labeling mix-ups
Action Spinal Elements sent an Urgent Medical Device Recall letter dated November 13, 2017. Instructions included to examine inventory and quarantine affected products, complete and return the response form, arrange for return of any affected product, and to notify customers if further distributed. For further questions, please call (770) 575-5274.
Quantity in Commerce 82 units
Distribution US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
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 = KWQ and Original Applicant = SPINE 360
-
-