The TM Ardis Interbody System implant is a convex recall
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…
Why was The TM Ardis Interbody System implant is a convex 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and identifiers are part of this recall.
- 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…
- Recalling firm
- Zimmer Trabecular Metal Technology, Inc.
- Quantity
- 299 units; 200 brochures
- Distribution
- Nationwide Distribution
- Recall date
- May 10, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)