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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 62916
Product Type Devices
Status Ongoing
Recalling Firm Extremity Medical LLC
City Parsippany
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-04-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist. Product coding is listed as Catalog Number: Lot Number and are as follows: 118-30014:107509; 118-30016:107510; 118-30018:107511; 118-30020:107512; 118-30020:107513; 118-30022:107514; 118-30024:107515; 118-30026:107516; 118-40020:107457; 118-40025:107458; 118-40030;107529; 118-40030;107459; 118-40035:107460; 118-40040:107461; 118-40045:107462; 118-40050:107463; 118-40320:107613; 118-40325:107614; 118-40330:107615; 118-40330:107616; 118-40335:107617; 118-40340:107618; 118-40345:107619; 118-40350:107620. Class II Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. 120 Units Z-0344-2013