Guide, Surgical, Instrument
135 catalogue numbers from 5843-15-02, 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
135catalogue 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 | 2016-05-26 |
| Record revised | 2021-11-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 60 to 100 cm; length 229 mm; lumen/inner diameter 3.5 to 8 mm |
| Distribution end date | 2017-05-16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5843-15-02 | Size E | In distribution | |
| 5120-71-38 | 38 mm Diameter | In distribution | |
| 5120-72-32 | 32 mm Diameter | In distribution | |
| 47-2255-008-00 | 2.4 mm Diameter | In distribution | |
| 5120-71-41 | 41 mm Diameter | In distribution | |
| 5967-65 | In distribution | ||
| 5843-12-02 | Size B | In distribution | |
| 5120-72-41 | 41 mm Diameter | In distribution | |
| 5843-15-01 | Size E | In distribution | |
| 5843-13-02 | Size C | In distribution | |
| 409-32 | 4.0 mm Tip Diameter, 2.4 mm Wire Diameter | In distribution | |
| 00-7806-009-00 | In distribution | ||
| 00-2366-040-00 | In distribution | ||
| 2360-36-32 | 3.2 mm Diameter | In distribution | |
| 5967-63 | In distribution | ||
| 409-44 | 4.0 mm Tip Diameter | In distribution | |
| 5120-71-46 | 46 mm Diameter | In distribution | |
| 5983-60-01 | Size A | In distribution | |
| 7712-54 | In distribution | ||
| 409-42 | 2.0 mm Tip Diameter | In distribution | |
| 6711-06 | Size 6/7 | In distribution | |
| 5843-21-02 | In distribution | ||
| 409-43 | 3.2 mm Tip Diameter | In distribution | |
| 5843-21 | 5 Degrees | In distribution | |
| 409-41 | 1.6 mm Diameter | In distribution | |
| 00-2366-030-00 | In distribution | ||
| 5843-22 | 5 Degrees | In distribution | |
| 5843-12-01 | Size B | In distribution | |
| 5967-62 | In distribution | ||
| 409-31 | Length 60 cm | In distribution | |
| 5843-25-05 | In distribution | ||
| 5843-14-02 | Size D | In distribution | |
| 5843-17-02 | Size G | In distribution | |
| 409-34 | 6.0 mm Tip Diameter, 3.2 mm Wire Diameter | In distribution | |
| 5843-25-02 | In distribution | ||
| 6711-08 | Size 8/9 | In distribution | |
| 5843-25-01 | Minus (-) 2 mm | In distribution | |
| 5843-16-01 | Size F | In distribution | |
| 5843-17-01 | Size G | In distribution | |
| 6890-03-010 | Size 0 | In distribution | |
| 2360-43-32 | 3.2 mm Diameter | In distribution | |
| 2360-43-16 | 1.6 mm Diameter | In distribution | |
| 5843-11-01 | Size A | In distribution | |
| 5983-60-03 | Size C | In distribution | |
| 5843-24 | In distribution | ||
| 6711-04 | Size 4/5 | In distribution | |
| 5983-60-05 | Size E | In distribution | |
| 5120-72-29 | 29 mm Diameter | In distribution | |
| 5120-71-51 | 51 mm Diameter | In distribution | |
| 5967-42 | In distribution | ||
| 6601-06-12 | 12/13 mm | In distribution | |
| 5843-11-02 | Size A | In distribution | |
| 6711-01 | Size 1/2 | In distribution | |
| 47-2255-08-01 | Length 100 cm | In distribution | |
| 5182 | In distribution | ||
| 409-33 | 5.0 mm Tip Diameter, 3.2 mm Wire Diameter | In distribution | |
| 5967-43 | Short | In distribution | |
| 72.09.01-10 | In distribution | ||
| 5120-71-35 | 35 mm Diameter | In distribution | |
| 6711-10 | Size 10/11/12 | In distribution | |
| 5175 | In distribution | ||
| 5843-23 | In distribution | ||
| 5120-72-38 | 38 mm Diameter | In distribution | |
| 00-2366-020-18 | In distribution | ||
| 2360-36-16 | 1.6 mm Diameter | In distribution | |
| 6890-00-607 | .040 Inch | In distribution | |
| 6091-09-110 | 9 Degree | In distribution | |
| 5967-66 | In distribution | ||
| 1179-99-80 | Lumen/Inner Diameter 8 mm | In distribution | |
| 5983-60-08 | Size H | In distribution | |
| 2360-33-32 | 3.2 mm Diameter | 5 | In distribution |
| 00-7806-009-45 | 45 Degree | In distribution | |
| 5061-45 | In distribution | ||
| 00-2366-022-18 | In distribution | ||
| 2255-08-01 | 3.0 mm Diameter | In distribution | |
| 5843-16-02 | Size F | In distribution | |
| 5843-13-01 | Size C | In distribution | |
| 1179-99-35 | Lumen/Inner Diameter 3.5 mm | In distribution | |
| 00-4089-008-07 | In distribution | ||
| 5843-25-04 | Minus (-) 2 mm | In distribution | |
| 5983-60-07 | Size G | In distribution | |
| 5983-60-02 | Size B | In distribution | |
| 5781-62 | In distribution | ||
| 5983-60-04 | Size D | In distribution | |
| 2360-33-16 | 1.6 mm Diameter | 5 | In distribution |
| 5120-72-35 | 35 mm Diameter | In distribution | |
| 2255-08 | Length 70 cm | In distribution | |
| 5983-60-06 | Size F | In distribution | |
| 5843-22-02 | In distribution | ||
| 6711-03 | Size 3 | In distribution | |
| 00-5843-056-00 | 2 mm Femoral/Tibial Recutter | In distribution | |
| 5843-14-01 | Size D | In distribution | |
| 6601-06-16 | 16/17 mm | Withdrawn | |
| 5983-04-94 | Length 229 mm | Withdrawn | |
| 5983-04-97 | Length 229 mm | Withdrawn | |
| 5983-64 | Size D | Withdrawn | |
| 5983-67 | Size G | Withdrawn | |
| 9366-00-050 | 3.2 mm Acetabular Drill Guide | Withdrawn | |
| 6890-03-705 | Size 0 | Withdrawn | |
| 6890-03-005 | .060 Blade | Withdrawn | |
| 5983-04-93 | 3 Degrees | Withdrawn | |
| 5983-56 | Size F | Withdrawn | |
| 5983-10-01 | Withdrawn | ||
| 5983-06-01 | Withdrawn | ||
| 5983-27-02 | Withdrawn | ||
| 5983-27-01 | Withdrawn | ||
| 5983-51 | Size A | Withdrawn | |
| 6601-06-14 | 14/15 mm | Withdrawn | |
| 5983-04-95 | 5 Degrees | Withdrawn | |
| 5983-68 | Size H | Withdrawn | |
| 31-8106-75 | Withdrawn | ||
| 6890-03-602 | Size 2 | Withdrawn | |
| 5983-65 | Size E | Withdrawn | |
| 5983-66 | Size F | Withdrawn | |
| 5983-06-03 | Plus (+) 3 mm | Withdrawn | |
| 5983-55 | Size E | Withdrawn | |
| 00-7806-009-23 | 23.5 Degree | Withdrawn | |
| 5983-58 | Size H | Withdrawn | |
| 5983-63 | Size C | Withdrawn | |
| 5983-57 | Size G | Withdrawn | |
| 6890-03-604 | Size 4 | Withdrawn | |
| 6890-03-601 | Size 1 | Withdrawn | |
| 5983-04-96 | 6 Degrees | Withdrawn | |
| 5983-54 | Size D | Withdrawn | |
| 6601-06-18 | 18 mm | Withdrawn | |
| 6890-03-605 | Size 5 | Withdrawn | |
| 00-7806-009-30 | 30 Degree | Withdrawn | |
| 31-8106-85 | Withdrawn | ||
| 6890-03-603 | Size 3 | Withdrawn | |
| 5983-62 | Size B | Withdrawn | |
| 9366-00-051 | 4.5 mm Acetabular Drill Guide | Withdrawn | |
| 5983-61 | Size A | Withdrawn | |
| 6601-06-10 | 10/11 mm | Withdrawn | |
| 6890-03-600 | Size 0 | Withdrawn | |
| 5983-52 | Size B | 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 |
| NexGen® | Zimmer, Inc. | 194 |
| Evolution® | Microport Orthopedics Inc. | 173 |
| Innomed, Inc. | Innomed, Inc. | 172 |
| Newclip Instruments | Newclip Technics SAS | 144 |
| 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.