FDA-Device2015-07-22Class II
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
Musculoskeletal Transplant Foundation, Inc.
Hazard
Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
Sold states
US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.
Affected count
117 units
Manufactured in
125 May St Ste 300, N/A, Edison, NJ, United States
Products
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2075-2015Don't want to check this manually?
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