Recall Z-0308-2011 ยท HSB Rod, Fixation, Intramedullary And Accessories
Integra LifeSciences Corporation
Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
| Date | Nov 2, 2010 (initiated Mar 1, 2010) |
| Status | Terminated |
| Reason | Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (Panta Support Device). |
| Root cause | Nonconforming Material/Component |
| Action | OIntegra issued Urgent Product Recall Notification letters dated 3/1/2010 to customers and distributors to notify them of the problem. Customers were requested to check their inventory to determine if they have an of the affected devices. If so, custo0mers should stop using the product. Custoemrs with the affected product should contact their local Sales Representative for assistance, or contact Integra at 800-654-2873 - 3 to obtain a returned material authorization number, and return the product to their local representative. All customers were requested to complete and return a Recall Ackno |
| Quantity | 108 Units |
| Distribution | Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VA, WA and WI; and countries of: Australia, Austria, Belgium, Czech Republica, Denmark, Finland, France, Germany, Ireland, Italy, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050882 | NEWDEAL ANKLE NAIL New Deal, S.A., May 27, 2005 |