Reported May 10, 2017 · Terminated
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior…
Zimmer Trabecular Metal Technology, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Trabecular Metal Technology, Inc. · 10 Pomeroy Rd · Parsippany, NJ · 07054-3722
Is this the product you have?
- The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
- Amount recalled
- 299 units; 200 brochures
Where it was sold
- Nationwide
Why it was recalled
This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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