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.
FDA Recall Z-0752-2013 · Posted 2013-01-30
Advertisement
Recalling FirmExtremity Medical LLC
Recall StatusTerminated
Product CodeHWC
Date Initiated2012-03-22
Date Terminated2013-06-13
Product Quantity93 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).
Firm 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.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement