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 |
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