ClearanceBrief
Recall Z-2199-2013 ยท HTZ Instrument, Cutting, Orthopedic

Tornier, Inc

AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the gl

DateSep 13, 2013 (initiated Aug 13, 2013)
StatusTerminated
ReasonFollowing 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
Root causeDevice Design
ActionTornier 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 ple
Quantity2,298 (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, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NE
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.