NexGen®
194 catalogue numbers from 5977-19-09, listed by Zimmer, Inc., United States, under Guide, Surgical, Instrument. 26 manufacturers in China are registered for this product code.
26manufacturers in China registered for this device type
194catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
Showing 12 of 26. All 26 manufacturers in China registered for Guide, Surgical, Instrument
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | FZX |
| Device type | Guide, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-05-24 |
| Record revised | 2022-03-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2017-04-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5977-19-09 | Size 9 mm | In distribution | |
| 5987-11-06 | Size F | In distribution | |
| 5983-33 | Size C | In distribution | |
| 5983-47 | Size G | In distribution | |
| 5987-60 | In distribution | ||
| 5978-72-03 | Size C | In distribution | |
| 5978-72-04 | Size D | In distribution | |
| 5978-72-07 | Size G | In distribution | |
| 00-5903-010-00 | In distribution | ||
| 5977-14 | In distribution | ||
| 82-0156-809-00 | 8 mm | In distribution | |
| 5983-48 | Size H | In distribution | |
| SSI004800 | 29mm | In distribution | |
| SSI004797 | 26mm | In distribution | |
| 5967-32 | Three Degree Distal | In distribution | |
| 82-0152-974-16 | D | In distribution | |
| SSI004614 | In distribution | ||
| 5967-11 | In distribution | ||
| 5977-19-20 | Size 20 mm | In distribution | |
| 5997-76 | 0 Degree Right Cut Guide | In distribution | |
| 5983-31 | Size A | In distribution | |
| 5987-14 | In distribution | ||
| 00-5853-012-51 | Size B | In distribution | |
| SSI004615 | In distribution | ||
| 00-5901-090-01 | 2 Degree | In distribution | |
| 82-0151-034-00 | In distribution | ||
| 83-5967-034-30 | Size D | In distribution | |
| 82-0152-974-18 | F | In distribution | |
| 00-5853-028-00 | In distribution | ||
| 5977-14-01 | Sizes 1-2 | In distribution | |
| 5983-32 | Size B | In distribution | |
| 82-0156-234-00 | 3 degrees | In distribution | |
| 82-0152-974-03 | F | In distribution | |
| 5977-62 | 2 Degree | In distribution | |
| 82-0152-974-02 | E | In distribution | |
| 00-5853-016-51 | Size F | In distribution | |
| 82-0152-974-00 | C | In distribution | |
| 00-5901-076-00 | 0 Degree | In distribution | |
| SSI004076 | In distribution | ||
| 5983-34 | Size D | In distribution | |
| 00-5853-015-51 | Size E | In distribution | |
| 82-0152-974-19 | G | In distribution | |
| 5977-14-03 | Sizes 3-4 | In distribution | |
| 00-5853-014-51 | Size D | In distribution | |
| 5983-35 | Size E | In distribution | |
| 5967-44-02 | 7 Degree | In distribution | |
| 5983-42 | Size B | In distribution | |
| 00-5901-064-00 | 0 Degree | In distribution | |
| 5967-44-01 | 7 Degree | In distribution | |
| 5978-72-05 | Size E | In distribution | |
| 00-5901-075-00 | 0 Degree | In distribution | |
| 5967-09-03 | In distribution | ||
| 5977-18-03 | Size Minus 3 mm | In distribution | |
| 5987-03 | In distribution | ||
| 5987-99 | In distribution | ||
| 5977-19-17 | Size 17 mm | In distribution | |
| 5978-72-08 | Size H | In distribution | |
| 00-5901-065-00 | 3 Degree | In distribution | |
| 82-0152-974-01 | D | In distribution | |
| 5987-12 | In distribution | ||
| 5987-33-01 | 5,10,15,20 mm | In distribution | |
| 5997-79 | 7 Degree Left Cut Guide | In distribution | |
| 5987-11-05 | Size E | In distribution | |
| 00-5901-078-00 | 7 Degree | In distribution | |
| 5978-72-01 | Size A | In distribution | |
| SSI004798 | 26mm | In distribution | |
| 5977-14-09 | Sizes 9-10 | In distribution | |
| 00-5977-084-10 | .050 Inch Thickness | In distribution | |
| 5977-24 | In distribution | ||
| 5987-11-02 | Size B | In distribution | |
| 5967-31 | Zero Degree Distal | In distribution | |
| 82-0152-974-15 | C | In distribution | |
| 5881-12-02 | Size B | In distribution | |
| 5967-60 | In distribution | ||
| 83-5967-041-30 | 4 Degrees | In distribution | |
| SSI004616 | In distribution | ||
| 5987-13-03 | Size 13-15 mm | In distribution | |
| 5987-13-04 | Size 16-18 mm | In distribution | |
| 5997-78 | 3 Degree Right Cut Guide | In distribution | |
| 5978-72-02 | Size B | In distribution | |
| 5987-13-05 | Size 19-21 mm | In distribution | |
| 5983-38 | Size H | In distribution | |
| 00-5901-079-00 | 0 Degree | In distribution | |
| 5881-12-01 | Size B | In distribution | |
| 5979-01-38 | Sizes 38 mm, 41 mm | In distribution | |
| 5978-72-06 | Size F | In distribution | |
| 5977-19-10 | Size 10 mm | In distribution | |
| 5977-19-23 | Size 23 mm | In distribution | |
| 5977-84 | .050 Inch Thickness | In distribution | |
| 5977-19-14 | Size 14 mm | In distribution | |
| 00-5901-063-00 | In distribution | ||
| 83-5967-042-30 | 4 Degrees | In distribution | |
| 82-0152-974-04 | G | In distribution | |
| 5977-14-02 | 15 mm Diameter | In distribution | |
| 5967-36 | In distribution | ||
| 5997-80 | 7 Degree Right Cut Guide | In distribution | |
| 5979-01-26 | Sizes 26 mm, 29 mm | In distribution | |
| 5977-14-05 | Sizes 5-6 | In distribution | |
| 5881-12-10 | Size B | In distribution | |
| 5979-01-32 | Sizes 32 mm, 35 mm | In distribution | |
| 5983-37 | Size G | In distribution | |
| 5987-13-06 | Size 16 – 18 mm, Size B | In distribution | |
| 83-5967-035-30 | Size E | In distribution | |
| 00-5901-077-00 | 7 Degree | In distribution | |
| 5997-77 | 3 Degree Left Cut Guide | In distribution | |
| 5967-15 | In distribution | ||
| 5977-95 | 2 mm Tibial Recutter | In distribution | |
| 5987-13-01 | Size 9-10 mm | In distribution | |
| SSI004617 | In distribution | ||
| 82-0153-023-00 | In distribution | ||
| 5987-11-07 | Size G | In distribution | |
| 83-5967-040-30 | In distribution | ||
| 5968-40 | In distribution | ||
| 83-5967-036-30 | Size F | In distribution | |
| 82-0152-974-17 | E | In distribution | |
| 5977-14-07 | Sizes 7-8 | In distribution | |
| 00-5901-090-00 | 2 Degree | In distribution | |
| 5978-03 | In distribution | ||
| 82-0156-094-00 | In distribution | ||
| SSI004799 | 29mm | In distribution | |
| 5997-83 | In distribution | ||
| 00-5901-067-00 | In distribution | ||
| 5987-19 | In distribution | ||
| 5983-36 | Size F | In distribution | |
| 00-5901-080-00 | 7 Degree | In distribution | |
| 5987-51-01 | In distribution | ||
| 5977-19-12 | Size 12 mm | In distribution | |
| 5983-41 | Size A | In distribution | |
| 5987-13-02 | Size 11-12 mm | In distribution | |
| 00-5853-013-51 | Size C | In distribution | |
| 5987-11-04 | Size D | In distribution | |
| 82-0156-095-21 | In distribution | ||
| 5977-12-14 | Size 4+ | In distribution | |
| SSI004618 | In distribution | ||
| 5983-43 | Size C | In distribution | |
| 5253-03 | .125 Inch Diameter | 3 | In distribution |
| 5987-70-01 | Size B | In distribution | |
| 5977-18-05 | Size Minus 5 mm | In distribution | |
| 5997-75 | 0 Degree Left Cut Guide | In distribution | |
| 5987-11-03 | Size C | In distribution | |
| 5978-64-07 | Size G | Withdrawn | |
| 5967-50-02 | Size B | Withdrawn | |
| 00-5967-034-30 | Size D | Withdrawn | |
| 5978-64-03 | Size C | Withdrawn | |
| 5967-50-03 | Size C | Withdrawn | |
| 5967-41 | Withdrawn | ||
| 00-5931-007-00 | 18 mm Tibial Stem Drill Guide | Withdrawn | |
| 5967-50-07 | Size G | Withdrawn | |
| 00-5967-040-30 | Withdrawn | ||
| 00-5967-061-30 | 6 Degrees | Withdrawn | |
| 5978-64-08 | Size H | Withdrawn | |
| 00-5967-042-30 | 4 Degrees | Withdrawn | |
| 00-5967-041-30 | 4 Degrees | Withdrawn | |
| 5253-17 | Withdrawn | ||
| 5978-09 | Withdrawn | ||
| 5967-72-06 | Size F | Withdrawn | |
| 00-5967-038-30 | Size H | Withdrawn | |
| 5967-50-08 | Size H | Withdrawn | |
| 5253-13 | Withdrawn | ||
| 00-5967-036-30 | Size F | Withdrawn | |
| 5967-50-05 | Size E | Withdrawn | |
| 5967-72-03 | Size C | Withdrawn | |
| 5978-61-02 | Size B | Withdrawn | |
| 5253-04 | 3 Degree Recutter | Withdrawn | |
| 5967-72-07 | Size G | Withdrawn | |
| 5978-61-08 | Size H | Withdrawn | |
| 5978-61-05 | Size E | Withdrawn | |
| 5967-72-02 | Size B | Withdrawn | |
| 00-5967-037-30 | Size G | Withdrawn | |
| 00-5967-033-30 | Size C | Withdrawn | |
| 5978-61-07 | Size G | Withdrawn | |
| 5987-77 | Size G | Withdrawn | |
| 00-5967-062-30 | 6 Degrees | Withdrawn | |
| 5978-64-02 | Size B | Withdrawn | |
| 5967-50-06 | Size F | Withdrawn | |
| 5978-64-04 | Size D | Withdrawn | |
| 5978-61-03 | Size C | Withdrawn | |
| 5967-72-04 | Size D | Withdrawn | |
| 5967-50-01 | Size A | Withdrawn | |
| 5253-15 | Withdrawn | ||
| 5978-12 | Withdrawn | ||
| 5987-73 | Size C/D | Withdrawn | |
| 5967-72-08 | Size H | Withdrawn | |
| 5978-61-06 | Size F | Withdrawn | |
| 5967-72-01 | Size A | Withdrawn | |
| 5978-61-01 | Size A | Withdrawn | |
| 5987-75 | Size E/F | Withdrawn | |
| 00-5967-035-30 | Size E | Withdrawn | |
| 5978-64-06 | Size F | Withdrawn | |
| 5978-64-01 | Size A | Withdrawn | |
| 5967-72-05 | Size E | Withdrawn | |
| 5967-50-04 | Size D | Withdrawn | |
| 5978-61-04 | Size D | Withdrawn | |
| 5978-64-05 | Size E | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 2,141 |
| Guide, Surgical, Instrument | Synthes Gmbh | 727 |
| DJO Surgical | DJO, LLC | 284 |
| Apex Knee System | Omni Life Science, Inc. | 272 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 223 |
| Motoband CP | Crossroads Extremity Systems LLC | 221 |
| Advance® | Microport Orthopedics Inc. | 199 |
| Evolution® | Microport Orthopedics Inc. | 173 |
| Innomed, Inc. | Innomed, Inc. | 172 |
| Newclip Instruments | Newclip Technics SAS | 144 |
| Guide, Surgical, Instrument | Zimmer, Inc. | 135 |
| Natural Knee® | Zimmer, Inc. | 134 |
Showing 12 of 1,788. All products under Guide, Surgical, Instrument
Recalls
5 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 |
|---|---|---|---|---|---|
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19,483 total products | 2020-11-18 |
| 2015-08-27 | Class II | Package design/selection | Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires. | 112,568 units | 2016-03-15 |
| 2013-11-19 | Class II | Labeling design | This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadve | 641 units | 2015-05-06 |
| 2013-11-19 | Class II | Labeling design | This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadve | 625 units | 2015-05-06 |
| 2013-11-05 | Class II | Process change control | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements fo | 42, 065 units total | 2015-05-05 |
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.