FDADecember 21, 2015device

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 Preservatio...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

conmed

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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