IO FiX X-Post Reamer recall
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…
Why was IO FiX X-Post Reamer recalled?
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.
- 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…
- Recalling firm
- Extremity Medical LLC
- Quantity
- 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.
- Recall date
- December 5, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)