IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Ex
FDA device recall Z-0344-2013 · posted 2012-11-18 · Terminated
Recall details
- Recalling firm
- Extremity Medical LLC
- Reason for recall
- Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 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.
- Date initiated
- 2011-04-13
- Date posted
- 2012-11-18
- Date terminated
- 2013-03-21
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM (K101700) | Extremity Medical, LLC | 2010-10-12 |