Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Reason for recall: Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. Distribution: US Nationwide. Global Distribution. Quantity: 868,363 total units Lot/code info: UDI-DI: 10705031026742, 10705031031234, 10705031032620, 10705031033894, 10705031134386, 10705031134492, 10705031118102, 10705031073487, 10705031149410, 10705031149427, 10705031075443, 10705031149441, 10705031149472, 10705031086906, 10705031130296, 10705031130302, 10705031082960, 10705031151819, 10705031130333, 10705031130357, 10705031130357, 10705031130418, 10705031130418, 10705031083028, 10705031130425, 10705031130562, 10705031151895, 10705031151895, 10705031151901, 10705031151918, 10705031130708, 10705031130722, 10705031131057, 10705031131057, 10705031461536, 10705031060340, 10705031113602, 10705031113619, 10705031060852, 10705031114050, 10705031060876, 10705031060883, 10705031114067, 10705031060890, 10705031060906, 10705031114074, 10705031114081, 10705031060913, 10705031114111, 10705031060968, 10705031060975, 10705031060982, 10705031114135, 10705031060999, 10705031061002, 10705031114142, 10705031114258, 10705031061132, 10705031061149, 10705031114265, 10705031114272, 10705031061156, 10705031061163, 10705031114296, 10705031061170, 10705031061187, 10705031061194, 10705031114319, 10705031061217, 10705031061224, 10705031114333, 10705031061231, 10705031467217, 10705031061248, 10705031114340, 10705031061255, 10705031061262, 10705031061279, 10705031061293, 10705031061309, 10705031061323, 10705031061347, 10705031061385, 10705031061460, 10705031061507, 10705031061538, 10705031061545, 10705031114654, 10705031061828, 10705031061835, 10705031061842, 10705031467354; Lot Numbers: RGMBEK,
10705031026742, 10705031031234, 10705031032620, 10705031033894, 10705031134386, 10705031134492, 10705031118102, 10705031073487, 10705031149410, 10705031149427, 10705031075443, 10705031149441, 10705031149472, 10705031086906, 10705031130296, 10705031130302, 10705031082960, 10705031151819, 10705031130333, 10705031130357, 10705031130418, 10705031083028, 10705031130425, 10705031130562, 10705031151895, 10705031151901, 10705031151918, 10705031130708, 10705031130722, 10705031131057, 10705031461536, 10705031060340, 10705031113602, 10705031113619, 10705031060852, 10705031114050, 10705031060876, 10705031060883, 10705031114067, 10705031060890
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.