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.
FDA Recall Z-0344-2013 · Posted 2012-11-18
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Recalling FirmExtremity Medical LLC
Recall StatusTerminated
Product CodeHWC
Date Initiated2011-04-13
Date Terminated2013-03-21
Product Quantity120 Units
Reason for Recall
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
Firm Action
Extremity Medical sent an e-mail notification (Extremity Medical- Sales Bulletin- IO Fix) dated April 13, 2011 to distributors notifying them of a change made to the 4.0 mm Lag Screw.
Root Cause
Employee error
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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