This article is more than 5 years old. Information may no longer be current.

Xiros releases urgent field safety notice for Infinity-Lock, disposable instrument set

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Xiros released an urgent field safety notice for the Infinity-Lock and disposable instrument set due to higher than anticipated intraoperative and postoperative implant or instrumentation failures.

According to the safety notice, the issues observed include the following:

- shearing of disposable hex driver head while applying torque in harder bone;

- cutting of tape implant by the screw during insertion in harder bone; and

- postoperative loss of reduction caused by incorrect surgical procedure, loosening of the screw because of poor bone quality and damage to the tape from unidentified causes.

Other potential hazards may include extended operative time while dealing with intraoperative issues and additional procedures to correct any postoperative issues, the release noted. Xiros urged hospitals and surgeons to return any remaining items to the company, including the Infinity-Lock implant set (102-1088) and the Infinity-Lock disposable instrument set (202-1088).

Reference:

mhra.filecamp.com/public/file/2jg0-3qqf798h