Recall Z-0752-2013— Extremity Medical LLC
Class II · Terminated
Class II FDA medical device recall by Extremity Medical LLC, initiated 2012-03-22, terminated 2013-06-13. It names 2 FDA 510(k) clearances: K121347, K101700. 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.. Reason: 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)..
- Recalling firm
- Extremity Medical LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-03-22
- Terminated
- 2013-06-13
- Firm location
- Parsippany, NJ, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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 device.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.