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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description AEQUALIS Reversed II or AEQUALIS 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 glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.
Recall Number Z-2199-2013
Classification Class II
Code Info all lots
Product Distributed Qty 2,298 (1045 US, 1253 OUS)
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 Revered Fracture instrument set tray no YKAD95.

Event Detail

Event Id 66057
Product Type Devices
Status Ongoing
Recalling Firm Tornier, Inc
City Bloomington
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern .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, NETHERLANDS, SLOVENIA, SPAIN, SWITZERLAND and UNITED KINGDOM
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