Reported Dec 5, 2012 · Terminated
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is…
Extremity Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Extremity Medical LLC · 300 Interpace Pkwy Ste 410A · Parsippany, NJ · 07054-1148
Is this the product you have?
- IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com
- Customer Service888.499.0079 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
- Lot codes and dates
- Product
- coding is listed as Catalog NumberLot
- Number and are as follows
118-0005:126564118-30016:127375118-30018:AP6A08118-30020:AP6A07
- Amount recalled
- 156 units
Where it was sold
Why it was recalled
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
This product could cause temporary or reversible health problems — stop using it.
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