Zimmer Peek Ardis Inserter Recall Issued Due to Breakages
Zimmer has recalled a medical device used during spinal fusion surgery, indicating that it may break inside patients’ bodies, causing internal injuries and blood loss.
On December 20, the FDA posted information about a Zimmer PEEK Ardis Inserter recall that was issued after the manufacturer, Zimmer Spine, received reports of the devices breaking during surgery.
Although there have been no post-operative complaints regarding the breakages, Zimmer warns that the fractured implants could cause dural tears and blood loss.
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Learn MoreThe Zimmer PEEK Ardis Inserter is used to implant the PEEK Ardis Interbody Spacer, a device used in posterior spinal fusion procedures. Zimmer estimates from reports that the inserters appear to be breaking at a rate of about 0.52 percent, or one out of roughly every 200.
The recall affects all lots of the PEEK Ardis Inserter, including inserters in the Ardis Instrument Set with part number 3256-01 and Specialty Ardis Inserters with part numbers 07.00780.701, 07.00780.702, 07.00900.702, 650-0176-01, 650-0179-01, 650-0208-01, 650-0239-01, 650-0263-01, 650-0293-01, 650-0297-01, 650-0351-01, 650-0351-02, and 650-0365-01. The part number and lot number are located on the inserters. The recalled medical devices were distributed from June 2008 through December 2012. About half were distributed in the U.S. and the rest were sold around the world.
Zimmer’s spinal subsidiary has warned surgeons and hospitals worldwide to immediately stop using the PEEK Ardis Inserter and return any in their inventory to Zimmer Spine. This also means that the PEEK Ardis Interbody Spacer cannot be used either, since it cannot be implanted without the Inserter.
Customers and distributors are being notified of the recall by mail. Any health care professionals with questions can call (866)774-368, can visit the website at www.peekardis.zimmer.com or can send an email to qualitycompliance@zimmer.com. Patients with questions are advised to consult their health care provider.
2 Comments
PhyllisMarch 25, 2020 at 5:13 pm
2009 through 2014 i had 3back surgery. 2012 The peek cage hardware became "loose hardware"and was surgically removed from back.But in the process of the removed a screw broke off in my back bone. And I feel like I should had being told that had a Recall on the "Peek Cage". I didn't know about a recall on the product so I don't it is fair to say my statue of limitations has expired.The I found a[Show More]2009 through 2014 i had 3back surgery. 2012 The peek cage hardware became "loose hardware"and was surgically removed from back.But in the process of the removed a screw broke off in my back bone. And I feel like I should had being told that had a Recall on the "Peek Cage". I didn't know about a recall on the product so I don't it is fair to say my statue of limitations has expired.The I found about a recall on the product was in 2019 -2020.
ChristopherOctober 31, 2015 at 11:02 pm
Received fusion (L5-S1) Oct 27, 2009. Had a break Oct 29, 2009. They PEEK cage was 'repaired' Nov 2, 2009. I have operative report and film. Not sure what broke or 'anchor fastener' broke or came loose 10/29/09.