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U.S. Department of Health and Human Services

Class 2 Device Recall Panta Arthrodesis Nail

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  Class 2 Device Recall Panta Arthrodesis Nail see related information
Date Initiated by Firm March 01, 2010
Date Posted November 02, 2010
Recall Status1 Terminated 3 on February 16, 2012
Recall Number Z-0308-2011
Recall Event ID 55242
510(K)Number K050882  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product 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.
Code Information Catalog number 519110, Kit S/N: PAN-001, PANTAXL-015; PAN-003, PANTAXL-017; PAN-004, PANTAXL-019; PAN-006, PANTAXL-020; PAN-013, PANTAXL-022; PAN-016, PANTAXL-026; PAN-018, PANTAXL-029; PAN-021, PANTAXL-031; PAN-023, PANTAXL-032; PAN-024, PANTAXL-033; PAN-025, PANTAXL-034; PAN-027, PANTAXL-035; PAN-030, PANTAXL-036; PAN-038, PANTAXL-039; PANTAXL-008, PANTAXL-040; PANTAXL-011, PANTAXL-042 & PANTAXL-012
Recalling Firm/
Manufacturer		 Integra LifeSciences Corporation
4900 Charlemar Dr Bldg A
Cincinnati OH 45227-1402
For Additional Information Contact
513-533-7923
Manufacturer 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).
FDA Determined
Cause 2		 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 Acknowledgement and Return Form..
Quantity in Commerce 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, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = NEWDEAL S.A.
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