Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12

FDA device recall Z-0367-2017 · posted 2016-11-29 · Terminated

Recall details

Recalling firm

Greatbatch Medical

Reason for recall

On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU).

Action taken

Greatbatch sent an Urgent Medical Device letter dated August 2, 2016, via FedEx to all affected consignees. The letter described the Reason for Field Correction Action, Risk to Health, and Instructions to Customers. Advised consignees to" immediately inform those responsible for sterilization of the devices to utilize the updated sterilization instructions, and post the attached notice where it is clearly visible to personnel who perform sterilization activities". Also instructed consignees to notify their customers and to complete and return the Field Correction Action Response Form. For questions contact your local Greatbatch Medical representative or 1-763-951-8235 or e-mail FieldActionCenter @Greatbatch.com.

Root cause

Under Investigation by firm

Status

Terminated

Product code

HWA

Quantity affected

4478 (2906 US, 1572 OUS)

Distribution

Worldwide Distribution - US including CA, IN, KS,NJ, NC, TN, TX, and UT and Internationally to ITALY, JAPAN, FRANCE, SPAIN, GERMANY, NETHERLANDS, GREECE, LUXEMBOURG, SOUTH KOREA, IRELAND, UNITED KINGD

Date initiated

2016-08-02

Date posted

2016-11-29

Date terminated

2017-07-27

Location

Plymouth, MN