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Recall Issued for Zimmer Spine Inc. PEEK Ardis Inserter

Recall Issued for Zimmer Spine Inc. PEEK Ardis Inserter

The PEEK Ardis Inserter is a surgical instrument that is used during spinal surgery to implant the PEEK ARDIS Interbody Spacer.

The FDA has already received reports of the PEEK Ardis inserter causing the PEEK Ardis interbody spacer to break into fragments when too much lateral force is applied by the tool. If this occurs and the PEEK Interbody spacer breaks during surgery surgical delays of up to 60 minutes can occur. This increased surgery time can lead to additional complications. Other risks include tears in the thin covering of the spinal cord (otherwise known as a dural tear), cerebrospinal fluid leakage, extreme blood loss, and even nerve injury. These injuries can cause long term health risks including disability, dysfunction, and death.

The affected models and lot numbers: Affected lots and part numbers are available on the FDA’s website.

Recalling Firm:
Zimmer Spine, Inc
7375 Bush Lake Road
Minneapolis, Minnesota 55439

Manufacturing and Distribution Dates: June 2008 – December 2012

The affected models and lot numbers: Affected lots and part numbers are available on the FDA’s website.

Recalling Firm:
Zimmer Spine, Inc
7375 Bush Lake Road
Minneapolis, Minnesota 55439

Public Contact: Questions should be directed to Zimmer Spine at 1-866-774-6368, Monday through Friday from 8 am to 5 pm Central Time.

FDA District: Detroit

FDA History: Initially, in November 2012, Zimmer Spine issued a Medical Device Correction memo to inform surgeons and hospitals of the problem and to provide updated precautions and surgical technique guidance to decrease the risk of implant breakage. In this memo, Zimmer Spine also indicated that on or about May 2013, a redesigned inserter would be available for use when implanting the PEEK Ardis Interbody Spacer.

On Dec. 20, 2012, Zimmer Spine modified their Medical Device Correction memo and initiated a voluntary recall of all 315 units of the PEEK Ardis Inserter. Surgeons and hospitals were instructed to immediately stop using the Ardis Inserter and to return them to Zimmer Spine. Surgeons and hospitals should be aware that surgery using the PEEK Ardis Interbody Spacer cannot be performed as intended without the use of the ArdisInserter. Therefore the PEEK Ardis Implant System will be unavailable for use until a redesigned inserter is cleared by the FDA.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

 

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