| | Class 2 Recall
Extremity Medical LLC |  |
| Date Posted |
January 30, 2013 |
| Recall Number |
Z-0752-2013 |
| 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, New Jersey 07054-1148 |
| For Additional Information Contact |
Mr. Jeffrey P. Zoleta
973-588-8980
|
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).
|
| 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. |
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