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ConMed Corporation recalls Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm
Recalled June 8, 2016 · FDA recall Z-1842-2016 · ConMed
Hazard
Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings. · FDA Class II
Units
991 pieces
Sold at
Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales
Description
Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.
Product
Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 The ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic surgical procedures
Manufacturer(s)
ConMed Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →