U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
조치
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.