Recall Z-0594-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Zimmer, Inc.
Zimmer Spine Ardis Inserter, Rx, non-sterile
| Date | Dec 22, 2012 (initiated Nov 12, 2012) |
| Status | Terminated |
| Reason | Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. Observed health risks |
| Root cause | Device Design |
| Action | Zimmer Spine, sent a "MEDICAL DEVICE CORRECTION" memo dated November 12, 2012 to all consignees / customers describing product, problem and actions to be taken including revised surgical technique. Beginning the week of December 17, 2012, Zimmer began the immediate retrieval of the affected units as a Class I recall. December 20, 2012 nation wide press outlining the recall was issued. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer Spine by calling 866-774-6368 between the hours of 8AM and 5PM CST or by email at qualitycompliance@z |
| Quantity | 315 (172 in USA) |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073202 | ARDIS SPACER Abbott Spine, Inc., Jan 30, 2008 |