Retractor f/Sciatic Nerve 의 리콜

Recall

79850

Class 2

Z-1758-2018

2018-04-02

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163734

There is a potential for microspores to form on the hollow handle of the sciatic nerve retractor. the pores may increase in size, allowing fluid to enter the hollow handle.

On April 2, 2018 Synthes (USA) LLC mailed an Urgent Product Recall notification letter to affected customers. Customers were instructed to: Review current inventory to identify and quarantine all affected products; Complete the Verification section of the Return Receipt form; Return affected product; Forward the notification to anyone in your facility that needs to be informed; If affected products have been forwarded to another facility, contact that facility to arrange return; Keep a copy of the notification. Customers with questions may call (610)719-5450 or contact your Depuy Synthese Sales Consultant.