The QMN Weekly Bulletin
Regulatory Affairs

Globus Warning Details Issues With Nonconforming Material

Nov. 15, 2013
The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet specification for mechanical testing. Memos attached to two nonconforming material reports discussed changes the company made to allow acceptance of the material via a handling evaluation instead of the validated mechanical test, according to the Sept. 26 letter posted online.
Devices & Diagnostics Letter