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Recall Observatory FDA recall evidence

Device product

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.

Z-0344-2013

April 13, 2011

Class II

Product summary

Firm
Extremity Medical LLC
Event
Event 62916
Status
Terminated
Classification
Class II
Quantity
120 Units
Official record key
device-enforcement:Z-0344-2013

Official wording

Reason: Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.

Code information: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.