Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the

FDA device recall Z-1736-2013 · posted 2013-07-16 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corporation

Reason for recall

As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.

Action taken

Integra initiated a voluntary correction on May 9, 2013 by providing a written notification and copy of the revised Surgical Technique Manual as well as the specific highlighted sections of the manual addressing calcaneal and tibial screw alignment to all consignees that Integra records indicate have been shipped a PANTA Nail. The written notifications and Surgical Technique Manual have been delivered to US Consignees by traceable courier service and by traceable email or facsimile for Canada and Non-US Consignees. The notification informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; advises customers to review highlighted revisions of the Surgical Technique Manual to minimize the potential for misalignment of the screws and requests customers to complete and return the attached Acknowledgement Return Form.

Root cause

Device Design

Status

Terminated

Product code

HSB

Quantity affected

692

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, Netherlands,

Date initiated

2013-05-09

Date posted

2013-07-16

Date terminated

2013-11-07

Location

Plainsboro, NJ

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