Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00526-1
Product Name/Description	Omega+ Lag Screw Ø13X110MM ST Item Number: 33625110 Lot Number: V06279 Ø13X105MM ST Item Number: 33625105 Lot Number: V06269 ARTG Number: 119660
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/04/2017
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker GmbH has received a customer complaint that the lag screw would not completely cannulate as the guide wire would not pass through the cannula of the screw. No harm was reported. It was found on investigation that the obstruction is related to a metal burr in the cannula of the screw which was not removed during manufacturing causing obstruction. The obstruction in the cannula of the screw is easily recognisable for the user. In most cases the surgeon would detect significant resistance when passing the lag screw over the guide wire before it touches the skin and would not continue using the screw. A different screw would be available and used, resulting in a minor delay in surgery of <15 minutes. If the surgeon does not notice or ignores the resistance, then surgical complications related to the guide wire being stuck in the cannulated screw and/or the guide wire being pushed out of the femoral head could theoretically occur.
Recall Action	Recall
Recall Action Instructions	Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate the return and replacement of the product. This action has been closed-out on 21/03/2018.
Contact Information	02 9467 1175 - Stryker