Smith & Nephew Aimer Endofemoral 의 리콜

Recall

55602

Class 2

Z-0041-2011

2010-04-29

2010-10-12

Terminated

United States

2012-05-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91310

Endofemoral aimer tip may separate due to failure of the soldered joint.

Smith & Nephew sent a "Medical Device Recall Information" letter dated April 29, 2010, with an attached "Urgent-Product Recall 1st Notification - Urgent" response form via Federal Express on April 29, 2010, to all customers. An e-mail was sent to the contacts in the identified OUS countries alerting them of the recall. ( Note: On June 24, 2010, the firm expanded the recall to include 4 additional catalog numbers 7220l713F, 72201714F, 72201715F, 722017l6F that are refurbished and one additional lot number to catalog Number: 72201714.) The letter described the product, problem and action to be taken by customers. The customers were instructed to immediately check stock for affected product; immediately remove the items from stock and set aside for quarantine; complete and return the attached Urgent-Product Recall 1st Notification - Urgent" response form, even if no product is being returned, via fax at +1-508-261-3636 attention Cindy Burns or email a PDF to Cindy.Burns@smith-nephew.com; call for a return Authorization number at 1-800-343-5717 Option #3, and return product to Smith & Nephew, Inc., Endoscopy Division as soon as possible. If you have any questions or require additional information, please contact Cindy Burns at 1-508-261-3655.