Deknatel
Green Braided PTFE Impregnated Polyester Fiber Size 6-0 36" KT-1 Needle K-2 Needle SybronEndo
6manufacturers in China registered for this device type
1,198catalogue numbers in this listing
9510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K001440 |
| Record published | 2015-10-16 |
| Record revised | 2026-04-13 (version 12) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: none |
| Packaging | Box of 36, sleeve, sleeve of 36, box of 12, box of 6, sleeve of 12 |
| Sizes | Length 30 to 180 cm; length 25.9 to 44.8 mm |
| Distribution end date | 2025-08-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN027091 | ‘silky’ II POLYDEK® /Needle AT-2, AT-2 Size-2-0 | In distribution | |
| IPN914473 | Length 45 cm | In distribution | |
| IPN038952 | TEVDEK® II /Needle KT-4, KT-4 Size-2-0 | In distribution | |
| IPN009360 | Length 75 cm | In distribution | |
| IPN049550 | Length 75 cm | In distribution | |
| IPN028732 | Length 45 cm | In distribution | |
| IPN009398 | ‘silky’ II POLYDEK® /Needle Size-2 | In distribution | |
| IPN011581 | POLYLENE /Needle HR17+ Size-3-0 | In distribution | |
| IPN011993 | TEVDEK® II /Needle HRT17, HRT17 Size-2-0 | In distribution | |
| IPN009696 | TEVDEK® II /Needle C-2, C-2 Size-2-0 | In distribution | |
| IPN012362 | TEVDEK® II /Needle T-3, T-3 Size-2-0 | In distribution | |
| IPN027031 | ‘silky’ II POLYDEK® /Needle T-5, T-5 Size-2-0 | In distribution | |
| IPN012302 | ‘silky’ II POLYDEK® /Needle DS40 Size-2 | In distribution | |
| IPN012633 | TEVDEK® II /Needle KT-3 Size-2-0 | In distribution | |
| IPN009406 | ‘silky’ II POLYDEK® /Needle KHT-3 Size-0 | In distribution | |
| IPN026845 | TEVDEK® II /Needle T-3 Size-4-0 | In distribution | |
| IPN028508 | TEVDEK® II /Needle T-5, T-5 Size-3-0 | In distribution | |
| IPN009854 | TEVDEK® II /Needle Size-3-0 | In distribution | |
| IPN026797 | Length 60 cm | In distribution | |
| IPN029057 | ‘silky’ II POLYDEK® /Needle DS26 Size-2-0 | In distribution | |
| IPN012617 | Length 75 cm | In distribution | |
| IPN009713 | TEVDEK® II /Needle XT-6.5, XT-6.5 Size-6-0 | 4 | In distribution |
| IPN028634 | ‘silky’ II POLYDEK® /Needle KHC-5 Size-2 | In distribution | |
| IPN055408 | ‘silky’ II POLYDEK® /Needle DS24 Size-2-0 | In distribution | |
| IPN029900 | Length 75 cm | In distribution | |
| IPN055417 | Length 75 cm | In distribution | |
| IPN038709 | TEVDEK® II /Needle KT-3 Size-2-0 | In distribution | |
| IPN011602 | POLYLENE /Needle HRT17 Size-3-0 | In distribution | |
| IPN027053 | TEVDEK® II /Needle KT-3, KT-3 Size-2-0 | In distribution | |
| IPN027010 | Length 90 cm | In distribution | |
| IPN009292 | Length 75 cm | In distribution | |
| IPN011738 | TEVDEK® II /Needle HRT20, HRT20 Size-2-0 | In distribution | |
| IPN038730 | Length 75 cm | In distribution | |
| IPN914488 | TEVDEK® II /Needle CE-1 Size-1 | In distribution | |
| IPN012592 | ‘silky’ II POLYDEK® /Needle KC-2, KC-2 Size-2-0 | In distribution | |
| IPN012608 | TEVDEK® II /Needle T-3 Size-2-0 | In distribution | |
| IPN027018 | Length 75 cm | In distribution | |
| IPN028724 | ‘silky’ II POLYDEK® /Needle Size-0 | In distribution | |
| IPN027020 | ‘cottony’™ II -TAPE /Needle HC-5 Size-1 mm | In distribution | |
| IPN027181 | TEVDEK® II /Needle T-3, T-3 Size-3-0 | In distribution | |
| IPN026959 | ‘cottony’™ II -TAPE /Needle K-61 Size-1 mm | In distribution | |
| IPN009903 | Length 75 cm | In distribution | |
| IPN038708 | TEVDEK® II /Needle KT-2 Size-2-0 | In distribution | |
| IPN029115 | TEVDEK® II /Needle HRT26, HRT26 Size-2-0 | In distribution | |
| IPN009374 | Length 60 cm | In distribution | |
| IPN009321 | Length 90 cm | In distribution | |
| IPN009852 | TEVDEK® II /Needle Size-5-0 | In distribution | |
| IPN028769 | TEVDEK® II /Needle Size-2 | In distribution | |
| IPN028682 | TEVDEK® II /Needle C-2, C-2 Size-2-0 | In distribution | |
| IPN012636 | Length 75 cm | In distribution | |
| IPN011783 | Length 75 cm | In distribution | |
| IPN009885 | TEVDEK® II /Needle KCE-75 Size-2 | In distribution | |
| IPN009354 | Length 75 cm | In distribution | |
| IPN029068 | TEVDEK® II /Needle DSM13 Size-5-0 | In distribution | |
| IPN012601 | TEVDEK® II /Needle C-2 Size-2-0 | In distribution | |
| IPN914503 | Length 75 cm | In distribution | |
| IPN038690 | Length 75 cm | In distribution | |
| IPN055439 | TEVDEK® II /Needle T-5V Size-2-0 | In distribution | |
| IPN009753 | Length 75 cm | In distribution | |
| IPN009744 | TEVDEK® II /Needle C-5 Size-0 | In distribution | |
| IPN011048 | Length 75 cm | In distribution | |
| IPN012606 | TEVDEK® II /Needle T-5V Size-2-0 | In distribution | |
| IPN012605 | TEVDEK® II /Needle T-5V Size-2-0 | In distribution | |
| IPN009424 | ‘silky’ II POLYDEK® /Needle KT-2, KT-2 Size-2-0 | In distribution | |
| IPN055476 | Length 45 cm | In distribution | |
| IPN009076 | Length 75 cm | In distribution | |
| IPN028776 | ‘silky’ II POLYDEK® /Needle SE-2 Size-2 | In distribution | |
| IPN009342 | Length 60 cm | In distribution | |
| IPN011790 | Length 45 cm | In distribution | |
| IPN009890 | TEVDEK® II /Needle KT-3, KT-3 Size-2-0 | In distribution | |
| IPN009411 | Length 75 cm | In distribution | |
| IPN049592 | TEVDEK® II /Needle HR26+ Size-0 | In distribution | |
| IPN029021 | Length 75 cm | In distribution | |
| IPN009841 | Length 75 cm | In distribution | |
| IPN028717 | Length 45 cm | In distribution | |
| IPN038665 | TEVDEK® II /Needle T-2 Size-2-0 | In distribution | |
| IPN055436 | TEVDEK® II /Needle KT-2 Size-2-0 | In distribution | |
| IPN009361 | Length 75 cm | In distribution | |
| IPN028616 | ‘silky’ II POLYDEK® /Needle CE-75, CE-75 Size-2 | In distribution | |
| IPN026803 | Length 75 cm | In distribution | |
| IPN011796 | TEVDEK® II /Needle K-60 Size-5 | In distribution | |
| IPN055419 | ‘silky’ II POLYDEK® /Needle C-5 Size-2-0 | In distribution | |
| IPN009880 | Length 75 cm | In distribution | |
| IPN011165 | TEVDEK® II /Needle C-2, C-2 Size-2-0 | In distribution | |
| IPN914536 | cottony’™ II /Needle Size-1 | In distribution | |
| IPN914547 | TEVDEK® II /Needle KT-3, KT-3 Size-2-0 | In distribution | |
| IPN927844 | Length 75 cm | In distribution | |
| IPN927839 | Length 75 cm | In distribution | |
| IPN009874 | Length 90 cm | In distribution | |
| IPN025299 | TEVDEK® II /Needle C-11 Size-0 | In distribution | |
| IPN009856 | Length 60 cm | In distribution | |
| IPN029269 | ‘silky’ II POLYDEK® /Needle CE-75 Size-5 | In distribution | |
| IPN009798 | TEVDEK® II /Needle T-1 Size-5-0 | In distribution | |
| IPN009914 | Length 75 cm | In distribution | |
| IPN009384 | ‘silky’ II POLYDEK® /Needle KC-2 Size-2-0 | In distribution | |
| IPN026814 | ‘silky’ II POLYDEK® /Needle AT-6, AT-6 Size-5-0 | In distribution | |
| IPN012765 | ‘silky’ II POLYDEK® /Needle KC-2, KC-2 Size-2-0 | In distribution | |
| IPN009796 | TEVDEK® II /Needle T-4 Size-2-0 | In distribution | |
| IPN009371 | ‘silky’ II POLYDEK® /Needle Size-5-0 | In distribution | |
| IPN009785 | Length 90 cm | In distribution | |
| IPN055415 | Length 75 cm | In distribution | |
| IPN009367 | Length 45 cm | In distribution | |
| IPN026924 | Length 75 cm | In distribution | |
| IPN009401 | ‘silky’ II POLYDEK® /Needle KHC-5 Size-0 | In distribution | |
| IPN012613 | Length 75 cm | In distribution | |
| IPN027033 | Length 75 cm | In distribution | |
| IPN029011 | TEVDEK® II /Needle KT-2 Size-2-0 | In distribution | |
| IPN914479 | Length 75 cm | In distribution | |
| IPN011161 | ‘silky’ II POLYDEK® /Needle C-2, C-2 Size-2-0 | In distribution | |
| IPN012597 | ‘silky’ II POLYDEK® /Needle KT-2, KT-2 Size-3-0 | In distribution | |
| IPN009365 | Length 45 cm | In distribution | |
| IPN028630 | Length 75 cm | In distribution | |
| IPN026973 | TEVDEK® II /Needle AT-6, AT-6 Size-5-0 | In distribution | |
| IPN027302 | Length 75 cm | In distribution | |
| IPN025294 | ‘silky’ II POLYDEK® /Needle C-7 Size-0 | In distribution | |
| IPN012637 | TEVDEK® II /Needle KC-2, KC-2 Size-2-0 | In distribution | |
| IPN011720 | Length 75 cm | In distribution | |
| IPN029064 | TEVDEK® II /Needle DS12 Size-5-0 | In distribution | |
| IPN009165 | ‘silky’ II POLYDEK® /Needle C-2 Size-2-0 | In distribution | |
| IPN026773 | Length 75 cm | In distribution | |
| IPN011791 | Length 45 cm | In distribution | |
| IPN055443 | TEVDEK® II /Needle C-2 Size-2-0 | In distribution | |
| IPN049552 | TEVDEK® II /Needle T-6, T-6 Size-5-0 | In distribution | |
| IPN055547 | Length 75 cm | In distribution | |
| IPN927773 | silky’ II POLYDEK® /Needle T-3 Size-2-0 | In distribution | |
| IPN028642 | ‘silky’ II POLYDEK® /Needle K-61 Size-5 | In distribution | |
| IPN009368 | Length 45 cm | In distribution | |
| IPN000843 | Suture Length 36″, Needle Length.787″ | In distribution | |
| IPN028748 | ‘cottony’™ II /Needle KHT-3 Size-1 | In distribution | |
| IPN028637 | ‘silky’ II POLYDEK® /Needle KC-7 Size-1 | In distribution | |
| IPN011570 | Length 45 cm | In distribution | |
| IPN028763 | ‘silky’ II POLYDEK® /Needle Size-1 | In distribution | |
| IPN028729 | TEVDEK® II /Needle Size-6-0 | In distribution | |
| IPN914502 | Length 90 cm | In distribution | |
| IPN009883 | TEVDEK® II /Needle KC-11 Size-1 | In distribution | |
| IPN011037 | ‘silky’ II POLYDEK® /Needle T-2, T-2 Size-4-0 | In distribution | |
| IPN011987 | Length 75 cm | In distribution | |
| IPN012594 | ‘silky’ II POLYDEK® /Needle KT-2, KT-2 Size-2-0 | In distribution | |
| IPN029898 | Length 75 cm | In distribution | |
| IPN009782 | TEVDEK® II /Needle T-1, T-1 Size-5-0 | In distribution | |
| IPN028617 | ‘silky’ II POLYDEK® /Needle CE-75, CE-75 Size-5 | In distribution | |
| IPN012634 | TEVDEK® II /Needle KT-3 Size-2-0 | In distribution | |
| IPN026845 | TEVDEK® II /Needle T-3 Size-4-0 | In distribution | |
| IPN026878 | TEVDEK® II /Needle KC-2, KC-2 Size-2-0 | In distribution | |
| IPN027155 | Length 75 cm | In distribution | |
| IPN011580 | POLYLENE /Needle DS30 Size-0 | In distribution | |
| IPN009830 | Length 75 cm | In distribution | |
| IPN009894 | Length 75 cm | In distribution | |
| IPN027085 | ‘silky’ II POLYDEK® /Needle T-5, T-5 Size-2-0 | In distribution | |
| IPN026943 | TEVDEK® II /Needle AT-6, AT-6 Size-5-0 | In distribution | |
| IPN027043 | ‘silky’ II POLYDEK® /Needle C-2, C-2 Size-2-0 | In distribution | |
| IPN026810 | Length 75 cm | In distribution | |
| IPN009755 | TEVDEK® II /Needle C-7 Size-1 | In distribution | |
| IPN914509 | TEVDEK® II /Needle C-2, C-2 Size-2-0 | In distribution | |
| IPN038679 | TEVDEK® II /Needle Size-2-0 | In distribution | |
| IPN027218 | ‘silky’ II POLYDEK® /Needle T-2, T-2 Size-3-0 | In distribution | |
| IPN009846 | TEVDEK® II /Needle Size-5-0 | In distribution | |
| IPN028678 | TEVDEK® II /Needle KT-3, KT-3 Size-2-0 | In distribution | |
| IPN000904 | Suture Length 18″, Two Needle Lengths @ 0.470″ | In distribution | |
| IPN028745 | Length 45 cm | In distribution | |
| IPN028523 | TEVDEK® II /Needle T-4 Size-2-0 | In distribution | |
| IPN026799 | TEVDEK® II /Needle T-2, T-2 Size-4-0 | In distribution | |
| IPN029017 | Length 75 cm | In distribution | |
| IPN049541 | Length 75 cm | In distribution | |
| IPN009882 | TEVDEK® II /Needle KC-7 Size-2 | In distribution | |
| IPN026944 | TEVDEK® II /Needle AT-6, AT-6 Size-5-0 | In distribution | |
| IPN002976 | Length 60 cm | In distribution | |
| IPN009277 | Length 75 cm | In distribution | |
| IPN027086 | Length 90 cm | In distribution | |
| IPN026835 | TEVDEK® II /Needle C-7, C-7 Size-0 | In distribution | |
| IPN028673 | TEVDEK® II /Needle AT-6, AT-6 Size-4-0 | In distribution | |
| IPN009408 | ‘silky’ II POLYDEK® /Needle KHT-3 Size-1 | In distribution | |
| IPN038694 | Length 90 cm | In distribution | |
| IPN009759 | TEVDEK® II /Needle CE-1 Size-2-0 | In distribution | |
| IPN029022 | Length 75 cm | In distribution | |
| IPN009753 | Length 75 cm | In distribution | |
| IPN027187 | TEVDEK® II /Needle KC-2, KC-2 Size-2-0 | In distribution | |
| IPN038878 | TEVDEK® II /Needle C-2, C-2 Size-2-0 | In distribution | |
| IPN027216 | Length 90 cm | In distribution | |
| IPN028553 | TEVDEK® II /Needle KT-3 Size-3-0 | In distribution | |
| IPN009687 | Length 75 cm | In distribution | |
| IPN027041 | Length 75 cm | In distribution | |
| IPN009408 | ‘silky’ II POLYDEK® /Needle KHT-3 Size-1 | In distribution | |
| IPN927852 | TEVDEK® II /Needle KC-2 Size-2-0 | In distribution | |
| IPN026943 | TEVDEK® II /Needle AT-6, AT-6 Size-5-0 | In distribution | |
| IPN009803 | Length 60 cm | In distribution | |
| IPN055412 | Length 75 cm | In distribution | |
| IPN029038 | POLYLENE /Needle DS30 Size-2-0 | In distribution | |
| IPN055430 | TEVDEK® II /Needle KT-2 Size-2-0 | In distribution | |
| IPN029067 | TEVDEK® II /Needle DSM10 Size-6-0 | In distribution | |
| IPN919126 | TEVDEK® II /Needle HRT26, HRT26 Size-2-0 | In distribution | |
| IPN009913 | TEVDEK® II /Needle KT-5V, KT-5V Size-2-0 | In distribution | |
| IPN027193 | TEVDEK® II /Needle KT-2, KT-2 Size-5-0 | In distribution | |
| IPN009428 | ‘silky’ II POLYDEK® /Needle KT-2, KT-2 Size-3-0 | In distribution | |
| IPN055409 | ‘silky’ II POLYDEK® /Needle DS26 Size-2-0 | In distribution | |
| IPN919139 | TEVDEK® II /Needle T-5, T-5 Size-3-0 | In distribution | |
| IPN038764 | Length 75 cm | In distribution | |
| IPN927847 | Length 75 cm | In distribution | |
| IPN009376 | ‘silky’ II POLYDEK® /Needle Size-0 | In distribution | |
| IPN055432 | TEVDEK® II /Needle C-2 Size-2-0 | In distribution | |
| IPN026795 | ‘cottony’™ II /Needle Size-1 | In distribution | |
| IPN029070 | TEVDEK® II /Needle K-60 Size-5 | In distribution | |
| IPN914486 | TEVDEK® II /Needle C-6 Size-1 | In distribution | |
| IPN027057 | ‘silky’ II POLYDEK® /Needle CE-2 Size-1 | In distribution | |
| IPN055438 | Length 75 cm | In distribution | |
| IPN027052 | TEVDEK® II /Needle KT-3, KT-3 Size-2-0 | In distribution | |
| IPN009359 | ‘silky’ II POLYDEK® /Needle T-5V, T-5V Size-2-0 | In distribution | |
| IPN000907 | Suture Length 36″, Needle 1 Length 0.470″, Needle 2 Length 0.700″ | In distribution | |
| IPN025294 | ‘silky’ II POLYDEK® /Needle C-7 Size-0 | In distribution | |
| IPN038941 | Length 75 cm | In distribution | |
| IPN027307 | Length 60 cm | In distribution | |
| IPN049551 | ‘silky’ II POLYDEK® /Needle C-5 Size-0 | In distribution | |
| IPN028735 | TEVDEK® II /Needle Size-5-0 | In distribution | |
| IPN919140 | Length 75 cm | In distribution | |
| IPN055416 | Length 75 cm | In distribution | |
| IPN919124 | Length 75 cm | In distribution | |
| IPN011740 | Length 75 cm | In distribution | |
| IPN000849 | Suture length 24″, Needle length 1.180″ | In distribution | |
| IPN027189 | Length 75 cm | In distribution | |
| IPN009378 | ‘silky’ II POLYDEK® /Needle Size-3-0 | In distribution | |
| IPN029041 | POLYLENE /Needle HS26 Size-0 | In distribution | |
| IPN055473 | Length 75 cm | In distribution | |
| IPN055544 | Length 50 cm | In distribution | |
| IPN009404 | ‘silky’ II POLYDEK® /Needle KHC-5 Size-2 | In distribution | |
| IPN009382 | Length 75 cm | In distribution | |
| IPN028723 | Length 60 cm | In distribution | |
| IPN009920 | Length 75 cm | In distribution | |
| IPN055441 | Length 75 cm | In distribution | |
| IPN028713 | ‘silky’ II POLYDEK® /Needle CE-75 Size-2 | In distribution | |
| IPN009377 | ‘silky’ II POLYDEK® /Needle Size-4-0 | In distribution | |
| IPN919123 | TEVDEK® II /Needle HRT20, HRT20 Size-2-0 | In distribution | |
| IPN055469 | Length 60 cm | In distribution | |
| IPN009364 | Length 75 cm | In distribution | |
| IPN049556 | TEVDEK® II /Needle KT-2, KT-2 Size-5-0 | In distribution | |
| IPN011993 | TEVDEK® II /Needle HRT17, HRT17 Size-2-0 | In distribution | |
| IPN027195 | Length 75 cm | In distribution | |
| IPN009286 | Length 90 cm | In distribution | |
| IPN029062 | TEVDEK® II /Needle HRT26, HRT26 Size-2-0 | In distribution | |
| IPN027314 | TEVDEK® II /Needle C-2, C-2 Size-2-0 | In distribution | |
| IPN029027 | Length 75 cm | In distribution | |
| IPN055411 | Length 90 cm | In distribution | |
| IPN914498 | Length 60 cm | In distribution | |
| IPN012355 | ‘silky’ II POLYDEK® /Needle C-2, C-2 Size-2-0 | In distribution | |
| IPN029071 | TEVDEK® II /Needle HRT17, HRT17 Size-2-0 | In distribution | |
| IPN009743 | Length 75 cm | In distribution | |
| IPN028566 | TEVDEK® II /Needle C-2, C-2 Size-3-0 | In distribution | |
| IPN009800 | Length 75 cm | In distribution | |
| IPN009826 | Length 75 cm | In distribution | |
| IPN029120 | ‘silky’ II POLYDEK® /Needle DS40 Size-2 | In distribution | |
| IPN009855 | TEVDEK® II /Needle Size-2-0 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
| HyperSuture | Threadstone LLC | 137 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260775 | 2026-05-06 |
| K192490 | 2020-03-30 |
| K191268 | 2019-06-11 |
| K181774 | 2018-10-10 |
| K172016 | 2017-10-03 |
| K100506 | 2010-03-10 |
| K063778 | 2007-02-09 |
| K040472 | 2004-03-15 |
| K033654 | 2004-01-15 |
Recalls
8 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 |
|---|---|---|---|---|---|
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. | 32,271 ea. | 2017-08-14 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. | 32,271 ea. | 2017-08-14 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
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 |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | 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.