Zimmer TM Ardis Interbody System Recalled for Procedural Error in Literature Approval
Zimmer Trabecular Metal Technology, Inc. is recalling the TM Ardis Interbody System due to a procedural error in the approval of literature, resulting in the unauthorized release of certain content.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and literature approval error rather than a physical defect in the implant itself.
Plain-English summary
Zimmer Trabecular Metal Technology, Inc. is recalling the TM Ardis Interbody System, a convex, straight TLIF or PLIF device used for interbody fusion of the anterior column of the spine. The recall involves 299 units and 200 brochures that were distributed nationwide.
The recall was initiated following the firm's discovery of a procedural error in the approval of literature. This error resulted in the unauthorized release of certain content, which was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held from February 17 to 21, 2016.
The TM Ardis device is designed to fuse adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in the L2-S1 region. The device is comprised of Trabecular Metal Porous Tantalum. Consumers and healthcare providers should contact the manufacturer for further instructions regarding the affected literature and devices.
The recalled product
- Product
- 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…
- Manufacturer
- Zimmer Trabecular Metal Technology, Inc.
- Category
- Medical Device — Spinal Implant
- Hazard
Distribution
Distributed nationwide across the United States.
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