IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is a
FDA device recall Z-0438-2013 · posted 2012-11-26 · Terminated
Recall details
- Recalling firm
- Extremity Medical LLC
- Reason for recall
- Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
- Action taken
- Extremity Medical sent a notification by e-mail that describes the "Slight modification to the Surgical Technique" on April 25, 2011. For questions regarading this recall call 973-588-8980.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 156 units
- Distribution
- Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland.
- Date initiated
- 2011-04-25
- Date posted
- 2012-11-26
- Date terminated
- 2013-03-21
- Location
- Parsippany, NJ
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