Stratafix
Knotless Tissue Control Device, Violet Unidirectional (Antibacterial) Synthetic Absorbable Device
2manufacturers in China registered for this device type
172catalogue numbers in this listing
9510(k) clearances naming this product code
24recalls on this code
Who Else Makes It
Concentrated in Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2015-09-01 |
| Record revised | 2023-07-25 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 30 °C |
| Packaging | Box of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SXPP1A407 | In distribution | |
| SXPP2B414 | In distribution | |
| SXPP1B424 | In distribution | |
| SXPP1A424 | In distribution | |
| SXPP1B412 | In distribution | |
| SXPP1A434 | In distribution | |
| SXPP2B433 | In distribution | |
| SXPP1A422 | In distribution | |
| SXPP1A406 | In distribution | |
| SXPP1A400 | In distribution | |
| SXPP1A203 | In distribution | |
| SXPP1B107 | In distribution | |
| SXPP1A437 | In distribution | |
| SXPP2B301 | In distribution | |
| SXPP1B403 | In distribution | |
| SXPP1B408 | In distribution | |
| SXPP1A205 | In distribution | |
| SXPP1B116 | In distribution | |
| SXPP2B412 | In distribution | |
| SXPP1A444 | In distribution | |
| SXPP1B415 | In distribution | |
| SXPP1B109 | In distribution | |
| SXPP2B101 | In distribution | |
| SXPP1B119 | In distribution | |
| SXPP1B112 | In distribution | |
| SXPP1B204 | In distribution | |
| SXPP1A439 | In distribution | |
| SXPP1A306 | In distribution | |
| SXPP1B101 | In distribution | |
| SXPP2B403 | In distribution | |
| SXPP1B420 | In distribution | |
| SXPP1B418 | In distribution | |
| SXPP1B423 | In distribution | |
| SXPP1B410 | In distribution | |
| SXPP1B201 | In distribution | |
| SXPP2B407 | In distribution | |
| SXPP2B400 | In distribution | |
| SXPP1B404 | In distribution | |
| SXPP1B405 | In distribution | |
| SXPP1B421 | In distribution | |
| SXPP1A418 | In distribution | |
| SXPP1B414 | In distribution | |
| SXPP1B413 | In distribution | |
| SXPP1A443 | In distribution | |
| SXPP1A417 | In distribution | |
| SXPP2B417 | In distribution | |
| SXPP1A101 | In distribution | |
| SXPP2B420 | In distribution | |
| SXPP1B108 | In distribution | |
| SXPP1B110 | In distribution | |
| SXPP2B413 | In distribution | |
| SXPP1B454 | In distribution | |
| SXPP1A201 | In distribution | |
| SXPP2B424 | In distribution | |
| SXPP1A200 | In distribution | |
| SXPP2B428 | In distribution | |
| SXPP1A420 | In distribution | |
| SXPP1B203 | In distribution | |
| SXPP1A416 | In distribution | |
| SXPP1A433 | In distribution | |
| SXPP1B422 | In distribution | |
| SXPP2B430 | In distribution | |
| SXPP1A409 | In distribution | |
| SXPP1B453 | In distribution | |
| SXPP2B408 | In distribution | |
| SXPP1A414 | In distribution | |
| SXPP1B114 | In distribution | |
| SXPP1A100 | In distribution | |
| SXPP2B202 | In distribution | |
| SXPP1B402 | In distribution | |
| SXPP1B456 | In distribution | |
| SXPP1A411 | In distribution | |
| SXPP1A413 | In distribution | |
| SXPP1A425 | In distribution | |
| SXPP2B429 | In distribution | |
| SXPP1B431 | In distribution | |
| SXPP1A447 | In distribution | |
| SXPP2B426 | In distribution | |
| SXPP1A300 | In distribution | |
| SXPP1A202 | In distribution | |
| SXPP1A440 | In distribution | |
| SXPP1A429 | In distribution | |
| SXPP1A438 | In distribution | |
| SXPP1B117 | In distribution | |
| SXPP1B106 | In distribution | |
| SXPP1B102 | In distribution | |
| SXPP2B100 | In distribution | |
| SXPP2B404 | In distribution | |
| SXPP2B423 | In distribution | |
| SXPP1A303 | In distribution | |
| SXPP1B401 | In distribution | |
| SXPP1B432 | In distribution | |
| SXPP1A431 | In distribution | |
| SXPP1A408 | In distribution | |
| SXPP1B450 | In distribution | |
| SXPP1B115 | In distribution | |
| SXPP1A428 | In distribution | |
| SXPP1A410 | In distribution | |
| SXPP1B104 | In distribution | |
| SXPP1A426 | In distribution | |
| SXPP1B425 | In distribution | |
| SXPP1A301 | In distribution | |
| SXPP2B431 | In distribution | |
| SXPP1A412 | In distribution | |
| SXPP1A446 | In distribution | |
| SXPP1B430 | In distribution | |
| SXPP2B435 | In distribution | |
| SXPP2B402 | In distribution | |
| SXPP1A423 | In distribution | |
| SXPP2B425 | In distribution | |
| SXPP1A403 | In distribution | |
| SXPP1A204 | In distribution | |
| SXPP1B457 | In distribution | |
| SXPP1B455 | In distribution | |
| SXPP1B407 | In distribution | |
| SXPP2B410 | In distribution | |
| SXPP1A304 | In distribution | |
| SXPP1A419 | In distribution | |
| SXPP1A441 | In distribution | |
| SXPP1B427 | In distribution | |
| SXPP1B202 | In distribution | |
| SXPP1A421 | In distribution | |
| SXPP1B409 | In distribution | |
| SXPP1A427 | In distribution | |
| SXPP2B419 | In distribution | |
| SXPP1B419 | In distribution | |
| SXPP1A415 | In distribution | |
| SXPP2B203 | In distribution | |
| SXPP2B436 | In distribution | |
| SXPP2B434 | In distribution | |
| SXPP2B415 | In distribution | |
| SXPP1B416 | In distribution | |
| SXPP1B452 | In distribution | |
| SXPP1B411 | In distribution | |
| SXPP1A302 | In distribution | |
| SXPP1B103 | In distribution | |
| SXPP1B429 | In distribution | |
| SXPP1B111 | In distribution | |
| SXPP2B102 | In distribution | |
| SXPP1B428 | In distribution | |
| SXPP2B405 | In distribution | |
| SXPP1A432 | In distribution | |
| SXPP1A442 | In distribution | |
| SXPP2B409 | In distribution | |
| SXPP1B105 | In distribution | |
| SXPP1B118 | In distribution | |
| SXPP1B433 | In distribution | |
| SXPP2B418 | In distribution | |
| SXPP1B113 | In distribution | |
| SXPP1A436 | In distribution | |
| SXPP2B427 | In distribution | |
| SXPP2B432 | In distribution | |
| SXPP2B200 | In distribution | |
| SXPP1B417 | In distribution | |
| SXPP1A435 | In distribution | |
| SXPP1A402 | In distribution | |
| SXPP1B451 | In distribution | |
| SXPP1B406 | In distribution | |
| SXPP2B300 | In distribution | |
| SXPP1A305 | In distribution | |
| SXPP1B426 | In distribution | |
| SXPP1A401 | In distribution | |
| SXPP2B401 | In distribution | |
| SXPP1A430 | In distribution | |
| SXPP1A405 | In distribution | |
| SXPP1B205 | In distribution | |
| SXPP1A445 | In distribution | |
| SXPP1A404 | In distribution | |
| SXPP2B201 | In distribution | |
| SXPP1B120 | In distribution | |
| SXPP1B458 | In distribution | |
| SXPP2B411 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeDIOX | Demetech Corp. | 994 |
| Monoplus | B Braun Surgical SA | 697 |
| PDS | Ethicon, Inc. | 430 |
| Wego-PDO Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 180 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 74 |
| PDO Max Threads | Max Pdo Inc | 64 |
| Assufil Monofilamento | Assut Europe | 50 |
| LES Encres | Meditime Co., Ltd. | 42 |
| DemeDIOX Barbed | Demetech Corp. | 40 |
| Viola | Meditime Co., Ltd. | 36 |
| Stratafix Spiral | Surgical Specialties México, S. de R.L. de C.V. | 34 |
| Unify PDO Surgical Sutures | Applied Dental, Inc. | 34 |
Showing 12 of 292. All products under Suture, Surgical, Absorbable, Polydioxanone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252047 | 2026-05-18 |
| K243897 | 2025-11-12 |
| K212380 | 2022-02-22 |
| K192144 | 2020-03-25 |
| K182873 | 2019-01-10 |
| K150670 | 2015-07-02 |
| K141776 | 2014-10-15 |
| K113004 | 2011-12-20 |
| K061037 | 2006-07-14 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ethicon, Inc. | UDI-DI | 2025-08-15 | Class II | Under Investigation by firm | Potential for barb non-engagement. | 516 units | |
| Ethicon, Inc. | UDI-DI | 2019-08-28 | Class II | Under Investigation by firm | The product do not meet certain internal testing specifications. | 3 units | 2021-02-11 |
| Ethicon, Inc. | UDI-DI | 2019-08-28 | Class II | Under Investigation by firm | The product do not meet certain internal testing specifications. | 660 units | 2021-02-11 |
| Ethicon, Inc. | UDI-DI | 2019-08-28 | Class II | Under Investigation by firm | The product do not meet certain internal testing specifications. | 133 units | 2021-02-11 |
| Ethicon, Inc. | UDI-DI | 2019-08-13 | Class II | Under Investigation by firm | The product does not meet certain internal strength testing specifications. | 416 each | 2021-02-11 |
| Ethicon, Inc. | UDI-DI | 2019-08-13 | Class II | Under Investigation by firm | The product does not meet certain internal strength testing specifications. | 852 each | 2021-02-11 |
Recalls
15 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-05-10 | Class II | Under Investigation by firm | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection. | 45828 units | |
| 2023-08-10 | Class II | Under Investigation by firm | Internal testing on returned product from this lot confirmed that some PDS” II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. | 868,363 total units | |
| 2023-08-10 | Class II | Under Investigation by firm | Internal testing on returned product from this lot confirmed that some PDS” II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. | 868,363 total units | |
| 2023-03-31 | Class II | Under Investigation by firm | Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved | 1,656 eaches (OUS only) | |
| 2022-11-16 | Class II | Under Investigation by firm | knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage | 7,560 eaches | |
| 2022-08-08 | Class II | Process control | Product may contain the incorrect material which could impact treatment. | 88 boxes (1056 ea) | |
| 2019-03-12 | Class II | Packaging process control | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. | 550,681 eaches (WW) Total | 2020-07-17 |
| 2019-03-12 | Class II | Packaging process control | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. | 550,681 eaches (WW) Total | 2020-07-17 |
| 2018-06-08 | Class II | Under Investigation by firm | Products do not meet a tensile strength specification | 72 | 2020-09-25 |
| 2018-06-08 | Class II | Under Investigation by firm | Products do not meet a tensile strength specification | 756 | 2020-09-25 |
| 2018-06-08 | Class II | Under Investigation by firm | Products do not meet a tensile strength specification | 4992 | 2020-09-25 |
| 2018-01-10 | Class II | Process control | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture. | 72 | 2019-04-11 |
| 2018-01-10 | Class II | Process control | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture. | 180 | 2019-04-11 |
| 2018-01-10 | Class II | Process control | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture. | 7020 | 2019-04-11 |
| 2013-09-25 | Class II | Unknown/Undetermined by firm | Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions. | 37,164 eaches | 2016-05-06 |
| 2009-02-02 | Not classified | Process control | Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process. | 1,758,360 total | 2009-10-21 |
| 2009-02-02 | Not classified | Process control | Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process. | 1,758,360 total | 2009-10-21 |
| 2009-02-02 | Not classified | Process control | Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process. | 1,758,360 total | 2009-10-21 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N18331 | 1986-06-06 | PDS SUTURE (DYED) | Ethicon, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.