Enforcement Report - Week of February 6, 2013
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Product Detail
| Product Description | Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic implant. |
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| Recall Number | Z-0752-2013 |
| Classification | Class II |
| Code Info | Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08. |
| Product Distributed Qty | 93 units |
| Reason For Recall | Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected). |
Event Detail
| Event Id | 63805 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Extremity Medical LLC |
| City | Parsippany |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-22 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA. |
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