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

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


New Search Back to Search Results
 Class 2 Recall
Fixed Cervical Screws		see related information
Date Posted March 08, 2013
Recall Number Z-0921-2013
Product 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Code Information Part Number: GCSF37512 and Lot Number: 0243
Recalling Firm/
Manufacturer		 Genesys Orthopedic Systems, LLC
1250 S Capital Of Texas Hwy
Bldg #3, Suite 600
Austin, Texas 78746-6446
For Additional Information Contact Joshua Kaufman
512-381-7070
Reason for
Recall		 Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
Action Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.
Quantity in Commerce 9 cervical screws
Distribution USA Nationwide Distribution including the states of: CA and TX.
 
-
-