Recalled Surgical Device

Written by Faith Anderson on December 21, 2012
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Medical Devices Affected by Recall

According to the medical device recall, hospitals and surgeons with PEEK Ardis Inserter instruments should immediately stop using the devices and return them to Zimmer Spine. Unfortunately, surgery using the PEEK Ardis Interbody Spacer cannot be performed as intended without the use of the inserter instrument. The Zimmer Spine recall includes all lots of the following part numbers, distributed from June 2008 through December 2012:

Inserter in Ardis Instrument Set 3256-01
Specialty Ardis Inserter 07.00780.701 650-0176-01 650-0239-01 650-0297-01
07.00780.702 650-0179-01 650-0263-01 650-0351-01
07.00900.701 650-0208-01 650-0293-02 650-0351-02
07.00900.702 650-0365-01

Contact an Experienced Attorney for Legal Help

Defective products can be identified by the lot number and part number physically marked on the surgical instrument. The medical devices were distributed across the United States and around the world, and Zimmer Spine is notifying its distributors and customers worldwide in order to arrange for the return of all recalled PEEK Ardis Inserters. If you have suffered injuries that you believe to be linked to the recalled surgical device, contact a knowledgeable attorney in your area. You may have grounds to file a product liability lawsuit against Zimmer Spine, in order to pursue financial compensation for your injuries and related medical bills.

Inserter in Ardis Instrument Set

Posted Under: FDA - Food and Drug Administration
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