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Biomet, Inc. recalls ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Recalled May 21, 2014 · FDA recall Z-1615-2014 · Biomet
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. · FDA Class II
Units
8 devices
Sold at
US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.
Description
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.
Product
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →