JETX(R) 6 MM X 25 MM SHORT HALF PIN TI6AL4V 의 리콜

Recall

61767

Class 2

Z-1749-2012

2012-04-13

2012-06-06

Terminated

United States

2015-09-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109003

Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.

Smith & Nephew Sales Representatives and Smith & Nephew International Distributors were notified of the problem with the affected product and the recall via email on April 13, 2012. All affected direct consignees were notified via Fed Ex on April 13, 2012. The Urgent Medical Device Recall letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the product and quarantine them immediately for return. Customers were instructed to complete the Inventory Return Certification Form included with the letter. Customers should fax or email the form to 901-566-7975 or fieldactions@smith-nephew.com. The affected product should be returned to: Smith & Nephew Attn: Global Field Actions Safety Affairs 1450 Brooks Road Memphis, Tennessee 38116 If the affected product was distributed further customers were instructed to provide a copy of the recall letter to these customers.