Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, moni

FDA device recall Z-0892-2013 · posted 2013-03-02 · Terminated

Recall details

Recalling firm

Ad-Tech Medical Instrument Corporation

Reason for recall

The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted. Recall expanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes.

Action taken

AD-TECH Medical Instrument Corporation sent an "Urgent Medical Device Recall" letter dated December 18, 2012 to all affected consignees. The letter described the Reason for the Voluntary Recall, Risk to Health, Actions to be taken by the Customer, Product and Distribution Information, Type of Action by Ad-Tech Medical Instrument Corporation and Other Information. Consignees were instructed to quarantine the affected product and contact the firm for a Return Material Authorization number. If the product have been further distributed consignees were advised to notify their customers of the recall. The letter requested consignees to return the Acknowledgement and Receipt Form. For questions contact your Ad-Tech Clinical Specialist. Expanded recall letters dated May 2, 2013 were sent out April 29, 2013. The letters were formatted as the initial ones sent on 12/18/2013.

Root cause

Device Design

Status

Terminated

Product code

GYC

Quantity affected

144 (103 US; 41 OUS)

Distribution

Worldwide Distribution - USA Nationwide including the states of CA, GA, LA, MA, MD, MI, MN, NH, PA, RI, TX, UT, WI, NY IA, WI and the countries of: Australia, CANADA, ENGLAND, JAPAN, KOREA, SPAIN, FRA

Date initiated

2012-12-18

Date posted

2013-03-02

Date terminated

2014-10-15

Location

Racine, WI

Related 510(k) clearances