Device Recall Offset Cup Impactor 의 리콜

Recall

67392

Class 1

Z-1119-2014

2014-01-31

2014-03-06

Terminated

United States

2016-10-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125387

Greatbatch medical has initiated a global field corrective action for the standard offset cup impactor since the product was first released in 2004. greatbatch has identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current instructions for use (ifu) provided with the device. the standard offset cup impactor is provided non-sterile and must be sterilized prior to use in a surgery. greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.

Greatbatch sent an Urgent Medical Device Field Corrective Action letter dated January 31, 2014, to all affected consignees. The letter was addressed to "Dear Valued Customer". The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. The instructions to customers included to review the enclosed Field Corrective Action Response Form, to examine their inventory and identify all Standard Offset Cup Impactors that are in their possession and immediately inform those responsible for sterilization to utilize the updated instructions. Also, advised consignees to immediately notify all customers of the Field Corrective Action and to complete and return the Field Corrective Action Response Form. For questions consignees were instructed to contact their local Greatbatch Medical representative at 1-763-951-8235 or e-mail them at FieldActionCenter@Greatbatch.com. For questions regarding this recall call 763-951-8235. UPDATED 3-28-2014: An updated Urgent Medical Device Correction letter was sent out to consignees 3/28/2014 to tell them of an additional validated sterilization parameter in addition to additional devices that are affected by the recall. A notice was asked to be posted where sterilization of the Standard Offset Cup Impactors occurs so personnel responsible for the sterilization of the devices would see the 2 validated cycles. A response form was asked to be returned to Greatbatch.