| Class 2 Device Recall Extremity Medical LLC | |
Date Initiated by Firm | March 22, 2012 |
Date Posted | January 30, 2013 |
Recall Status1 |
Terminated 3 on June 13, 2013 |
Recall Number | Z-0752-2013 |
Recall Event ID |
63805 |
510(K)Number | K101700 K121347 |
Product Classification |
Screw, fixation, bone - Product Code HWC
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Product | 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 device. |
Code Information |
Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08 |
Recalling Firm/ Manufacturer |
Extremity Medical LLC 300 Interpace Pkwy Ste 410A Parsippany NJ 07054-1148
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For Additional Information Contact | Mr. Brian A. Smekal 973-588-8988 |
Manufacturer 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). |
FDA Determined Cause 2 | Device Design |
Action | Extremity Medical LLC sent e-mail notification dated March 22, 2012, to all affected customers. The email identified the product the problem and the action to be taken by the customers.
The email includes a buleeting which informes the customer that an upgrade to the existing instrumentation is being released. The upgrade will replace the existing gauge. Updated pdf versions of the technique guide are also included. Customers are instructed to return the recalled device after swapping out the recalled device with the replacement unit. Customers will be contacted by Extremity and Sales Reps should contact their principal.
For further questions please call (973) 588-8980. |
Quantity in Commerce | 93 units |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HWC 510(K)s with Product Code = HWC
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