Device Recall DePuy P.F.C. Sigma Knee System, NonPorous Cruciate Retaining Femoral Component

Lot Numbers: 2833275, 2833276, 2833277, 2833278, 2833279, 2835157, 2835908, 2835909, 2837020, 2838165, 2839666, 2839667, 2839668, 2839670, 2839671, 2839672, 2839675, 2840479, 2840480, 2841253, 2842526, 2842527, 2842528, 2842930, 2843263, 2843265, 2843267, 2843268, 2843270, 2844381, 2844383, 2844386, 2844796, 2844799, 2844800, 2845530, 2845534, 2846326, 2846330, 2846332, 2852392, 2852394, 2855015, 2855016, 2857271, 2857272, 2857881, 2857882, 2857884, 2857885, 2858572, 2858573, 2858574, 2858576, 2858577, 2859195, 2859197, 2859198, 2859199, 2859915, 2859916, 2859917, 2859920, 2860448, 2860449, 2860452, 2860455, 2860456, 2861519, 2861520, 2861699, 2862589, 2862591, 2863841, 2863843, 2864833, 2864834, 2864835, 2864837, 2864839, 2866038, 2868313, 2868314, 2869119, 2869120, 2869121, 2869122, 2869123, 2871182, 2871183, 2871835, 2871836, 2874434, 2874435, 2874436, 2876307, 2876309, 2876311, 2876314, 2881638, 2885685, 2885689, 2886278, 2886968 and 2886974.

Orthopedic Devices

2

Yes

Nationwide.

DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. || The device is used for total or unicompartmental knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.