--- title: "PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05... — FDA record Z-2617-2023 | Is It on Recall" description: "Internal testing on returned product from this lot confirmed that some PDS\" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement." url: https://isitonrecall.com/recall/fda-device-z-2617-2023-pds-ii-polydioxanone-suture-product-numbers-z844g-50-d10065-05-d10085-05-d6776-05-d6776-05-d9297-05/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05... — FDA record Z-2617-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Aug 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 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, Z493G-50, Z493G-50, Z493G-50, Z493G-50, Z494G-50, Z495G-05, Z495G-05, Z495G-05, Z496G-50, Z496G-50, Z496G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z503G-50, Z504G-50, Z507G-50, Z507G-50, Z683G-05, Z833G-05, Z833G-05, Z844G-50 - **Reason**: Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. - **Classification**: Class II - **Recalling firm**: ETHICON, LLC - **Quantity**: 868,363 total units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2617-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2617-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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, 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 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide. Global Distribution. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Sep 27, 2023 - **Recall initiation date**: Aug 10, 2023 - **Center classification date**: Sep 20, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2617-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [ETHICON, LLC records](https://isitonrecall.com/brand/ethicon-llc/)