Reported Nov 28, 2012 · Terminated

IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The…

Extremity Medical LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Extremity Medical LLC · 300 Interpace Pkwy Ste 410A · Parsippany, NJ · 07054-1148

IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com
Customer Service888.499.0079. 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

Lot codes and dates: Product
coding is listed as Catalog NumberLot
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
Amount recalled: 120 Units

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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