Skip to content

PDS II (polydioxanone) Suture, Product Numbers Z844G-50… recallZ-2617-2023 · Ethicon, LLC · initiated Aug 10, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT: MEDICAL DEVICE RECALL (REMOVAL) notification letter dated 8/10/23 was sent to customers. ACTION REQUIRED 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to Sedgwick at 877-550-0702 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused PDS" Sutures subject to this recall that are in inventory immediately. To receive credit reimbursement, customers must return product subject to this recall no later than November 30, 2023. Any non-affected product and any product returned after the date specified will not receive credit reimbursement. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Sedgwick at 877-479-8088. Your account number and mailing address have been pre-populated on the BRF. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 7. If product subject to this recall is contained in a custom kit, please contact you

Recall details

Recall number
Z-2617-2023
Status
Open, Classified
Initiated by the company
Aug 10, 2023
Posted by the FDA
Sep 30, 2024
Recalling firm
Ethicon, LLC
Quantity
868,363 total units
Product code
NEW
Distribution
US Nationwide. Global Distribution.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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

Devices named in this recall

28 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92843).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page