medical Class II Updated 2023-09-27

ETHICON, LLC recalls PDS Plus Antibacterial (polydioxanone) Suture, Product Numbe

Recalled Product

PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16

Hazard / Issue

Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 10705031122574, 10705031047952, 10705031048232, 10705031048294, 10705031048300, 10705031048393, 10705031123786, 10705031048447, 10705031123854, 10705031123854, 10705031123861, 10705031203969, 10705031203983, 10705031204010, 10705031204034, 10705031048546, 10705031048553, 10705031124059, 10705031124677, 10705031124691, 10705031124707, 10705031124714, 10705031124752, 10705031124752, 10705031124769, 10705031124875, 10705031124899, 10705031123540, 10705031123564, 10705031123588, 10705031123595; Lot Numbers: RLMCKU, RLMEAL, RLMDST, RMMHLT, RJMMAC, SCMASA, RKMQDX, RKMBEB, SAMERU
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