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. 2015 Nov 19;474(4):1053–1068. doi: 10.1007/s11999-015-4634-x

Table 6.

FDA Recalls of PMA-approved orthopaedic devices

Date of recall Device trade name PMA number Device manufacturer FDA recall class Reason for recall Recall termination date
June 7, 2007 Birmingham HipTM Resurfacing (BHR®) System P040033 Smith & Nephew Inc. 2 Mislabeling of sizes Open
October 25, 2007 Birmingham HipTM Resurfacing (BHR®) System P040033 Smith & Nephew Inc. 2 Mislabeling of sizes February 2, 2010
December 19, 2007 Prestige® Cervical Disc System P060018 Medtronic Sofamor Danek USA, Inc. 2 Implant misseating November 3, 2008
September 29, 2008 X-Stop® Interspinous Process Decompression System P040001 Kyphon Inc. 2 Clarification of physician instructions July 14, 2009
October 20, 2008 Ray Threaded Fusion Cage™ with Instrumentation P950019 Stryker Corp. 2 Incorrect labeling November 4, 2008
February 3, 2009 Oxford™ Meniscal Unicompartmental Knee System P010014 Biomet, Inc. 2 Mislabeling of left/right July 7, 2009
June 25, 2009 Nexgen® LPS-Flex Mobile and LPS-Mobile Bearing Knee System P060037 Zimmer Inc. 2 Inadequate implant polishing November 12, 2009
July 27, 2009 Trilogy® AB Acetabular System P040048 Zimmer Inc. 2 Inadequate package seal December 22, 2009
August 4, 2009 ABC/Trident® Ceramic-Ceramic Hip Articulation P000013 Stryker Corp. 2 Clarified physician instructions Open
May 21, 2010 Euflexxa ®(1% Sodium Hyaluronate) P010029 Ferring Pharmaceuticals Inc. 3 Viscosity out of specification July 27, 2010
April 22, 2011 Reflection® Ceramic Acetabuluar System P030022 Smith & Nephew Inc. 2 Damaged during processing February 8, 2012
February 4, 2013 Trilogy® AB Acetabular System P040048 Zimmer, Inc. 2 Low porosity specification June 20, 2014
June 25, 2013 Infuse® Bone Graft/ LT-Cage® Lumar Tapered Fusion Device P000058 Medtronic Sofamor Danek USA, Inc. 2 Possible contamination May 13, 2014
October 25, 2013 Nexgen® LPS-Flex Mobile and LPS-Mobile Bearing Knee System P060037 Zimmer, Inc. 2 Packaging breakdown September 25, 2014
February 20, 2014 Trilogy® AB Acetabular System P040048 Zimmer, Inc. 2 Poor packaging at one manufacturing plant Open
May 26, 2015 LCS® Total Knee System P830055 DePuy Orthopaedics, Inc. 2 High revision rates Open
September 10, 2015 Birmingham HipTM Resurfacing (BHR®) System P040033 Smith & Nephew Inc. 2 High revision rates Open