Recall Z-0075-2011 ยท NKB Thoracolumbosacral Pedicle Screw System
Zimmer Inc.
Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)
| Date | Oct 18, 2010 (initiated Apr 13, 2010) |
| Status | Terminated |
| Reason | The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip. |
| Root cause | Device Design |
| Action | Zimmer Spine issued an "Urgent Medical Device Correction" letter through the Zimmer Spine sales force to be provided to PathFinder system users in February 2010. the letter identified the affected product, safety issue, and actions to be taken by customers. Customers will receive replacement devices with a design change for the recalled devices, as they are available from the manufacturer. |
| Quantity | 1471 (888 subject to removal) |
| Distribution | Worldwide Distribution: USA including states of AZ, CA, CO, FL, GA, LA, MI, MN, MO, NC, NH, NY, OH, OK, PA, TN, TX, WA, and WI, and the countries of Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey, UK and Switzerland. |
| FDA record | Open on fda.gov |