Recall Z-0344-2013— Extremity Medical LLC

Name: FDA recall Z-0344-2013
Creator: U.S. Food and Drug Administration
Published: 2011-04-13

Class II · Terminated

Class II FDA medical device recall by Extremity Medical LLC, initiated 2011-04-13, terminated 2013-03-21. It names one FDA 510(k) clearance: K101700. Product: IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.. Reason: Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively..

Recalling firm: Extremity Medical LLC
Classification: Class II
Status: Terminated
Initiated: 2011-04-13
Terminated: 2013-03-21
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K101700 — IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEMExtremity Medical, LLC·cleared 2010-10-12

K-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

IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.

Reason for recall

Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.

Data sourced from openFDA. This site is unofficial and independent of the FDA.