Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Recalls In Brief

This article was originally published in The Gray Sheet

Executive Summary

Synthes recall: Firm is recalling Synex II Central Body components used in its Synex II modular vertebral body replacement system after receiving reports of moderate to severe loss in device height six to 15 months after implantation. The Class I recall could pose "an imminent hazard" to patients, Synthes says, including neural injury, increased pain, spinal kyphosis (a curving of the spine), failure of supplementary fixation, or the need for revision surgery. The firm initiated the global recall Sept. 14, urging surgeons and hospitals to stop implanting the devices and to annually monitor implanted patients through radiographs and pain assessments

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT028151

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel