Recall Z-1892-2017 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Zimmer Trabecular Metal Technology, Inc.
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 verte
| Date | Jul 7, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Zimmer Biomet sent an Urgent Medical Device Correction Notice dated July 7, 2016, to all consignees on the list requiring them to destroy all literature and notify Zimmer Biomet of others who they have disseminated the material further. Retraining the sales force on the use of the TM Ardis. The details of the strategy are contained within the Draft Recall Strategy attached to the email transmitting this report. For further questions, please call (973) 576-0032. |
| Quantity | 299 units; 200 brochures |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113561 | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION Zimmer Trabecular Metal Technology, May 29, 2012 |