Device Recall PANTA Arthrodesis Nail Support Device 의 리콜

Recall

65406

Class 2

Z-1736-2013

2013-05-09

2013-07-16

Terminated

United States

2013-11-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118787

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.

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.