Stratafix
Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Device
4manufacturers in China registered for this device type
90catalogue numbers in this listing
27510(k) clearances naming this product code
21recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Sichuan Innovation Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 2 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K221744 |
| Record published | 2016-10-20 |
| Record revised | 2023-07-20 (version 8) |
Specifications
| MRI safety | MR Safe |
|---|---|
| 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; Special storage condition: Do not use if package is damaged |
| Packaging | Box of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SXMP1B110 | In distribution | |
| SXMP1B413 | In distribution | |
| SXMP1B447 | In distribution | |
| SXMP1B427 | In distribution | |
| SXMP1B433 | In distribution | |
| SXMP1B442 | In distribution | |
| SXMP1B411 | In distribution | |
| SXMP2B151 | In distribution | |
| SXMP1B414 | In distribution | |
| SXMP2B420 | In distribution | |
| SXMP1B420 | In distribution | |
| SXMP2B417 | In distribution | |
| SXMP1B111 | In distribution | |
| SXMP1B426 | In distribution | |
| SXMP2B404 | In distribution | |
| SXMP2B403 | In distribution | |
| SXMP2B402 | In distribution | |
| SXMP1B115 | In distribution | |
| SXMP1B105 | In distribution | |
| SXMP1B448 | In distribution | |
| SXMP1B116 | In distribution | |
| SXMP1B454 | In distribution | |
| SXMP1B117 | In distribution | |
| SXMP2B413 | In distribution | |
| SXMP2B405 | In distribution | |
| SXMP1B410 | In distribution | |
| SXMP1B436 | In distribution | |
| SXMP1B417 | In distribution | |
| SXMP1B106 | In distribution | |
| SXMP1B425 | In distribution | |
| SXMP1B445 | In distribution | |
| SXMP1B431 | In distribution | |
| SXMP1B428 | In distribution | |
| SXMP2B407 | In distribution | |
| SXMP1B452 | In distribution | |
| SXMP2B409 | In distribution | |
| SXMP1B434 | In distribution | |
| SXMP2B150 | In distribution | |
| SXMP1B430 | In distribution | |
| SXMP1B450 | In distribution | |
| SXMP1B455 | In distribution | |
| SXMP2B421 | In distribution | |
| SXMP2B408 | In distribution | |
| SXMP1B419 | In distribution | |
| SXMP1B108 | In distribution | |
| SXMP2B423 | In distribution | |
| SXMP1B416 | In distribution | |
| SXMP1B119 | In distribution | |
| SXMP1B438 | In distribution | |
| SXMP2B401 | In distribution | |
| SXMP1B103 | In distribution | |
| SXMP1B444 | In distribution | |
| SXMP1B102 | In distribution | |
| SXMP2B427 | In distribution | |
| SXMP1B408 | In distribution | |
| SXMP1B113 | In distribution | |
| SXMP1B101 | In distribution | |
| SXMP1B437 | In distribution | |
| SXMP2B412 | In distribution | |
| SXMP1B429 | In distribution | |
| SXMP1B453 | In distribution | |
| SXMP2B400 | In distribution | |
| SXMP1B118 | In distribution | |
| SXMP1B120 | In distribution | |
| SXMP1B441 | In distribution | |
| SXMP1B409 | In distribution | |
| SXMP1B412 | In distribution | |
| SXMP2B422 | In distribution | |
| SXMP1B443 | In distribution | |
| SXMP1B421 | In distribution | |
| SXMP2B410 | In distribution | |
| SXMP1B424 | In distribution | |
| SXMP2B152 | In distribution | |
| SXMP1B104 | In distribution | |
| SXMP1B440 | In distribution | |
| SXMP2B411 | In distribution | |
| SXMP2B415 | In distribution | |
| SXMP2B406 | In distribution | |
| SXMP1B415 | In distribution | |
| SXMP1B432 | In distribution | |
| SXMP1B114 | In distribution | |
| SXMP1B107 | In distribution | |
| SXMP2B419 | In distribution | |
| SXMP1B451 | In distribution | |
| SXMP1B449 | In distribution | |
| SXMP2B414 | In distribution | |
| SXMP2B416 | In distribution | |
| SXMP2B418 | In distribution | |
| SXMP1B435 | In distribution | |
| SXMP1B109 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novosyn | B Braun Surgical SA | 2,286 |
| DemeCRYL | Demetech Corp. | 2,092 |
| DemeSORB | Demetech Corp. | 1,625 |
| Safil | B Braun Surgical SA | 1,613 |
| Monosyn | B Braun Surgical SA | 1,096 |
| E-Pack | Ethicon, Inc. | 967 |
| Coated Vicryl | Ethicon, Inc. | 933 |
| DemeQUICK | Demetech Corp. | 732 |
| Polysorb | Covidien LP | 732 |
| DemeCAPRONE | Demetech Corp. | 707 |
| Wego-PGA Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 554 |
| Safil Quick+ | B Braun Surgical SA | 414 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253394 | 2026-06-25 |
| K253852 | 2026-02-06 |
| K252743 | 2025-12-22 |
| K221744 | 2022-11-15 |
| K201996 | 2020-12-21 |
| K192580 | 2019-12-18 |
| K183183 | 2019-06-27 |
| K181652 | 2018-09-28 |
| K161726 | 2016-07-12 |
| K153611 | 2016-06-03 |
| K151200 | 2015-08-13 |
| K142822 | 2015-03-26 |
| K132580 | 2014-02-28 |
| K050845 | 2005-06-29 |
| K033746 | 2003-12-18 |
| K032420 | 2003-10-22 |
| K022715 | 2002-12-19 |
| K022269 | 2002-09-13 |
| K974299 | 1998-02-13 |
| K970317 | 1997-04-25 |
| K964345 | 1996-12-16 |
| K962480 | 1996-08-02 |
| K946271 | 1995-06-15 |
| K944110 | 1995-01-18 |
| K930772 | 1994-01-07 |
| K930360 | 1993-12-17 |
| K915835 | 1992-03-23 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Ethicon, Inc. | 510(k) number | 2024-03-08 | Class II | Under Investigation by firm | Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility | 395 units |
Recalls
11 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 |
|---|---|---|---|---|---|
| 2024-09-25 | Class II | Under Investigation by firm | Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package. | 31,032 units | |
| 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. | 287892 units | |
| 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. | 341532 units | |
| 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. | 56952 units | |
| 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. | 55296 units | |
| 2022-09-20 | Class II | Under Investigation by firm | Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair | 2,280 eaches | |
| 2022-03-24 | Class II | Employee error | Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. | 2808 (all OUS) | |
| 2020-09-09 | Class II | Packaging process control | Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL sut | 1,032 eaches (OUS only) | 2023-11-07 |
| 2020-01-03 | Class II | Process control | Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point. | 23688 units | 2021-08-13 |
| 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 |
| 2017-08-17 | Class II | Equipment maintenance | On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damag | 129,372 Eaches (Internationally) | 2019-05-08 |
| 2010-04-20 | Not classified | Other | Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe. | 118332 eaches were sent to the US Distribution Center, of wh | 2011-07-19 |
| 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 |
| 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 |
| 2008-08-11 | Not classified | Packaging | Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product. | 6912 | 2012-06-05 |
| 2006-05-04 | Not classified | Other | Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures. | 1157 dozens | 2007-12-17 |
| 2006-02-16 | Not classified | Other | The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations. | 1,061,712 sutures | 2006-12-07 |
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 |
|---|---|---|---|
| P840051 | 1989-06-07 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. |
| N18387 | 1987-06-18 | PDS(TM) SUTURE (CLEAR) | Ethicon, Inc. |
| N16881 | 1981-12-04 | DEXON | Davis & Geck, 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.