According to the latest press release from the FDA, Zimmer Spine Inc. one of the renowned names in the field of medical device manufacturing has issued a voluntary worldwide recall of all 315 units of the PEEK Ardis® Inserter. The recalled product, “Ardis Inserter” is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer. According to the federal agency the recall was initiated because Zimmer Spine has received reports of PEEK Ardis Interbody Spacer implant breakage when the implant is subjected to excessive lateral and/or off-axis forces from the inserter during surgery.

The company has asked health care professionals, operation units and patients to stop using this device immediately as it may cause serious health injuries to patients. Observed health risks associated with implant fragments may include Dural tears and blood loss. No post-operative complaints have been reported that are attributed to a fractured implant still the recall was issued as a part of precautionary measure to avoid any such incidence in future. Patients with concern about their implant should contact their healthcare provider and seek for the necessary advice.

This recall includes all lots of the following part numbers that were distributed from June 2008

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
07.00780.701 650-0208-01 650-0293-01 650-0351-02
07.00900.702 650-0365-01

Products can be identified by the part number and lot number physically marked on the surgical instrument. Products were distributed nationwide in the United States and around the world. Zimmer Spine has notified the FDA of this action and is working with other regulatory agencies worldwide.

Further information, including a detailed listing of part and lot numbers, can be found at www.peekardis.zimmer.com. Patients, customers and health care professionals may report adverse events or quality problems experienced with the use of these products to Zimmer Spine by calling 866-774-6368 between  8 AM and 5 PM CST or by email at qualitycompliance@zimmer.com. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

About Zimmer Spine

Zimmer is one of the leaders in joint replacement solutions for hip pain, knee pain, and provides comprehensive spine care solutions for acute and chronic back pain. Zimmer offers a broad range of dental implant, trauma and orthopedic surgical products. The company came into existence in the year of 1927, and is committed to providing effective techniques in hip replacement and knee replacement for orthopedic surgeons who restore mobility and relieve the pain of osteoarthritis and traumatic injuries.