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FDA device recall Z-1535-2015 · posted 2015-04-27 · Terminated

Recall details

Recalling firm

Biocare Medical, LLC

Reason for recall

A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.

Action taken

Biocare sent a Medical Device Notification letters dated March 17, 2015 to all affected sites. The letters identify the affected product, problem, actions to be taken and the fact that it affects all identified lots shipped between 02/13/13 and / 01/28/15. The letters instructed customers to immediately discontinue further use of the recalled lots, dispose of them according to state and local regulations and complete the response form and returned by April 7, 2015. Credit will be issued upon receipt of the response form.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

NJT

Quantity affected

44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314

Distribution

Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.

Date initiated

2015-03-17

Date posted

2015-04-27

Date terminated

2015-06-15

Location

Concord, CA