Recall Z-0438-2013— Extremity Medical LLC
Class II · Terminated
Class II FDA medical device recall by Extremity Medical LLC, initiated 2011-04-25, terminated 2013-03-21. FDA's recall record names no specific 510(k) clearance for this event. Product: IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.. Reason: Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming..
- Recalling firm
- Extremity Medical LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-04-25
- Terminated
- 2013-03-21
- Firm location
- Parsippany, NJ, United States
Product description
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
Reason for recall
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Data sourced from openFDA. This site is unofficial and independent of the FDA.