FDA-Device2014-05-21Class II
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Biomet, Inc.
Hazard
This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
Sold states
US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.
Affected count
8 devices
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1615-2014Don't want to check this manually?
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