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.
FDA Recall Z-0308-2011 · Posted 2010-11-02
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Recalling FirmIntegra LifeSciences Corporation
Recall StatusTerminated
Product CodeHSB
Date Initiated2010-03-01
Date Terminated2012-02-16
Product Quantity108 Units
Reason for Recall
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).
Firm 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 Acknowledgement and Return Form..
Root Cause
Nonconforming Material/Component
Distribution Pattern
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, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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