AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed I

FDA device recall Z-2199-2013 · posted 2013-09-13 · Terminated

Recall details

Recalling firm

Tornier, Inc

Reason for recall

Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R

Action taken

Tornier sent an "Urgent Medical Device Recall" letter dated August 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were advised to cease further use and distribution of the product and to contact all end users. Also requested the completion and return of the attached questionnaire via fax to 952-236-4007, e-mail to CustomerServices@Tonier.com or using the envelope provided. We apologize for the incovenience and thank you in advance for your cooperation in this matter. If you have any questions please contact our Customer Service Department at 1-888 494-7950.

Root cause

Device Design

Status

Terminated

Product code

HTZ

Quantity affected

2,298 (1045 US, 1253 OUS)

Distribution

.Worldwide Distribution - USA including Puerto Rico and the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN, NE, NJ, NC, OH, OR, PA and TX., and the countries of CANADA, MEXICO, HONG KONG,

Date initiated

2013-08-13

Date posted

2013-09-13

Date terminated

2015-03-03

Location

Bloomington, MN