Codman(R) Collins Radioparent Sternal Blade Nylon 의 리콜

Recall

64962

Class 2

Z-1267-2013

2013-04-10

2013-05-07

Terminated

United States

2014-05-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117536

There is a possibility that the collins radioparent sternal blades nylon may break during use.

Symmetry Surgical sent an Urgent Medical Device Recall letter dated April 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to discontinue use of the product immediately and promplty call 800-251-3000 for a return material authorization (RMA) number and to identify if they would like credit or an alternative product. Customers were asked to fill out the attached Recall Response Form and fax the completed form to 615-964-5567. Customers with questions were instructed to call 615-964-5515. For questions regarding this recall call 615-964-5515.