Enforcement Report - Week of December 5, 2012
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Event Detail
| Event ID | 62918 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Extremity Medical LLC |
| City | Parsippany |
| State | NJ |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-04-25 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures. | Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07. | Class II | Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming. | 156 units | Z-0438-2013 |
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