Device Recall TiBond 의 리콜

Recall

70044

Class 2

Z-0907-2015

2014-12-18

2015-01-05

Terminated

United States

2015-03-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132185

Spinal elements is recalling the ti-bond related brochures that includes lt-10000 and mp-14000 (all revisions) the content regarding the ti-bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications.

Spinal Elements sent an Urgent Field Action letter dated December 22, 2014, to all affected customers. The letter informed the customers to cease all distribution of the literature material. The letter informed the customers that the content regarding the Ti-Bond coating in the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications. In addition to the customer notiification letter, it will include a list of claims related to the field action. The letter also informed customers of the actions to be taken. Customers were instructed to immediately examine their literature inventory, discontinue the use and /or distribution of the affected brochure, destroy all copies or send them back to: Spinal Elements, Inc. 3115 Melrose Drive Carlsbad, CA 92010 If product was further distributed customers should identify those customers and notify them at once. Customers were also instructed to complete and return the enclosed "Customer Response Form." For questions regarding this recall call 760-607-0121, ext 206. Customers with questions were instructed to contact Customer Service at 1-877-SPINALS, ext 213. Customers with questions were instructed to contact Customer Service at (877) SPINAL5 Ext 213.