Device Recall GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT 의 리콜

Recall

66333

Class 2

Z-0445-2014

2013-08-27

2013-12-04

Completed

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122068

The tyvek(tm) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email. For questions regarding this recall call 901-396-2121.