Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- 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.