—#114205

Product

The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.

FDA product code: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K113561
Affected lot / code info: Part number: 96-701-10001; Lot numbers: 61946711, 61946712, 61991588, 62000412,

Why it was recalled

Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer sent a "MEDICAL DEVICE CORRECTION" letter dated September 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Risk Manager Confirmation Form was attached for customers to complete and return. Questions and concerns should be addressed to Zimmer Spine Customer Service at 866-774-6368. When re-design is approved, Zimmer will remove and replace all affected devices.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: USA nationwide; Europe, Sweden

Timeline

Recall initiated: 2012-09-20
Posted by FDA: 2013-01-09
Terminated: 2014-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114205. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.