Reported Sep 27, 2023 · Ongoing

PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05,…

Ethicon, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ETHICON, LLC · 475 Calle C Ste 401 · Guaynabo, PR · 00969-4292

Is this the product you have?

89 of 89 codes
- PDS II (polydioxanone) Suture
- Product Numbers Z844G-50
- D10065-05
- D10085-05
- D6776-05
- D6776-05
- D9297-05
- D9297-05
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z259H-50
- Z416H-50
- Z416H-50
- Z416H-50
- Z416H-50
- Z416H-50
- Z416H-50
- Z416H-50
- Z416H-50
- Z421H-50
- Z421H-50
- Z421H-50
- Z422H-50
- Z422H-50
- Z422H-50
- Z422H-50
- Z422H-50
- Z422H-50
- Z422H-50
- Z423H-50
- Z423H-50
- Z423H-50
- Z442H-50
- Z442H-50
- Z442H-50
- Z443H-50
- Z443H-50
- Z443H-50
- Z443H-50
- Z443H-50
- Z443H-50
- Z443H-50
- Z443H-50
- Z489G-50
- Z489G-50
- Z489G-50
- Z489G-50
- Z493G-50

Lot codes and dates: UDI-DI
92 of 92 codes
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
Lot NumbersRGMBEK, QMMCKS, QLMKHK, REMMRB, RKMASZ, PBM649, SJMLRE, PG6842, QJMCQC, QLMBXL, QKMKRK, QLMDJA, QLMJQH, QMMAKJ, QMMLBP, QPMCMQ, RCMJDB, RCMPXB, RDMERH, RGMDMM, RGMDBJ, SCMJET, REMJAJ, MKZ221, QPMDDQ, QPMDHD, RBMAJE, RGMAQU, RHMBMR, RLMPMM, QGMHTJ, QKMMPQ, RCMKHS, MMK957, QMMCPS, RDMKAJ, REMKDP, QHMMPR, RKMAAS, SGMCTP, REMBUE, RKMMTD, SCMAXS, QHMEDK, REMEQC, RJMPQP, QKMHTR, QLMKPU, QMMHUU, RAMLZJ, RDMACU, RDMECL, RGMLCS, SCMELT, QBMBQA, QBMKCR, RPMBJS, SBMJZM, QLMDDC, QLMPAR, QPMBDT, RGMBBK, RHMJHU, QHMMEP, QLMDDQ, QMMBQJ, RCMRUD, RGMALA, RCMBDB, TBMDPK, PGZ426, QKMHTM, QKMHRP, QLMHBX, QPMBMD, QPMDBX, RCMJEK, RDMDAS, RKMDJA, RLMHPQ, QPMCAD, RGMDBP, QCMCZZ, RJMLEL, TAMQSS, MPZ365, SCMBJZ, RBMEDE
Amount recalled: 868,363 total units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50…

Where it was sold

Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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