Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Sphe...
FDA Recall #Z-1842-2016 — Class II — December 21, 2015
Product Description
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
Reason for Recall
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.
Recalling Firm
ConMed Corporation — Utica, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
991 pieces
Distribution
Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales
Code Information
Lot Numbers: 1) 569449, 577583, 577969, 579655, 580365, 581176, 581198, 582216, 587320, 594569, 658219, 669615, 673913 & 688136; 2) 569462, 577800, 577971 & 579652; 3) 569468, 577835, 577974, 579650, 583736, 583742, 587514, 627923, 659317 & 664751.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated