Zimmer Spine, Inc., has launched an URGENT voluntary worldwide recall of all 315 units of their PEEK Ardis Inserter. Below you will find some important information about the product recall along with helpful tips regarding product return.
What is the Ardis Inserter?
The Ardis Inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer.
Reason For Recall:
According to the FDA, the inserters are being recalled because Zimmer Spine has received reports that the inserters have caused the PEEK Ardis Interbody Spacer implants to break during spinal surgery. The breakage of the spacer implants apparently occurs when the spacer implant becomes subjected to excessive lateral and/or off-axis forces from the inserter during surgery.
Health Risks Associated with Implant Breakage:
- Dural tears
- Blood loss
Recalled Product Information:
- Recalling Firm: Zimmer Spine, Inc.
- Recall Date: December 20, 2012
- Distribution Dates: Between June 2008 through December 2012
For a list of all the recalled units, visit the FDA recall page.
Injuries to Date:
The complaint reports indicate that the injuries that have taken place during the spinal surgery have occurred at a rate of 0.52%. However, no post-operative complaints attributed to a fractured implant have been reported.
Product Return Information:
Surgeons and hospitals with the recalled PEEK Ardis Inserter instruments in their inventories should immediately stop using the inserters. They should also return them to Zimmer Spine. Zimmer Spine is contacting its distributors and customers worldwide and is arranging for the return of all PEEK Ardis Inserters.
Health care professionals and consumers, who have experienced negative reactions using these inserters should report their adverse reactions or quality problems to Zimmer Spine by calling 866-774-6368. Moreover, patients with concerns about their implant should contact their healthcare provider.
Adverse reactions or quality problems may also be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. You may report the problem to MedWatch by either mailing in the reporting form, submitting the report online, or by fax to 1-800-FDA-0178.
For additional information regarding this worldwide recall, visit the Zimmer Spine, Inc.’s website.
What to Do if You Have Been Affected by a Recalled Product:
If you or a loved one has become injured as a result of a recalled product, you may be entitled to compensation. It would be beneficial to speak to an attorney specializing in products liability. Most of the attorneys here at LawInfo.com offer free initial consultations, so it would be advantageous to at least talk to an attorney and get some feedback.
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