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U.S. Department of Health and Human Services

Class 2 Device Recall AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor.

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 Class 2 Recall
AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor.
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Date Posted September 13, 2013
Recall Status1 Open
Recall Number Z-2199-2013
Recall Event ID 66057
Product Classification Instrument, Cutting, Orthopedic - Product Code HTZ
Product 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 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.
Code Information all lots
Recalling Firm/
Manufacturer
Tornier, Inc
10801 Nesbitt Ave S
Bloomington, Minnesota 55437-3109
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 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, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NETHERLANDS, SLOVENIA, SPAIN, SWITZERLAND and UNITED KINGDOM
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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