SynthesTitanium Polyaxial Reduction Head for Titanium Matrix Spine Screws 의 리콜

Recall

69603

Class 1

Z-0226-2015

2014-10-23

2014-11-26

Terminated

United States

2015-08-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131023

Two nonconforming parts of the titanium polyaxial reduction head for titanium matrix spine screws may have been inadvertently packaged and shipped. it is believed that the inner diameter of the reduction head may not have been machined to the correct specification.

DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated October 23, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check inventory and remove affected stock, call Synthes to obtain a Return Authorization for the device, and to return the completed verification section of the response form by fax to (610) 430-7083 or Scan/email: Fieldaction@synthes.com. Customers with questions were instructed to call 610-719-5450.