Recall Z-0344-2013 ยท HWC Screw, Fixation, Bone
Extremity Medical LLC
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.
| Date | Nov 18, 2012 (initiated Apr 13, 2011) |
| Status | Terminated |
| Reason | Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. |
| Root cause | Employee error |
| Action | Extremity Medical sent an e-mail notification (Extremity Medical- Sales Bulletin- IO Fix) dated April 13, 2011 to distributors notifying them of a change made to the 4.0 mm Lag Screw. |
| Quantity | 120 Units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101700 | IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM Extremity Medical, LLC, Oct 12, 2010 |