NCB
3 catalogue numbers from 82-0199-090-00, listed by Zimmer, Inc., United States, under Orthopedic Manual Surgical Instrument. 53 manufacturers in China are registered for this product code.
53manufacturers in China registered for this device type
3catalogue numbers in this listing
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-07-26 |
| Record revised | 2023-05-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 82-0199-090-00 | In distribution | |
| 02.00002.001 | In distribution | |
| 02.00024.364 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
Recalls
40 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 |
|---|---|---|---|---|---|
| 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2019-04-18 | Class II | Nonconforming Material/Component | Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. | 14 units | 2020-09-10 |
| 2019-04-18 | Class II | Nonconforming Material/Component | Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. | 3 units | 2020-09-10 |
| 2019-04-18 | Class II | Nonconforming Material/Component | Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. | 41 units | 2020-09-10 |
| 2019-04-18 | Class II | Nonconforming Material/Component | Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. | 15 | 2020-09-10 |
| 2019-04-18 | Class II | Nonconforming Material/Component | Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. | 10 units | 2020-09-10 |
| 2019-04-18 | Class II | Nonconforming Material/Component | Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. | 11 units | 2020-09-10 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 1676 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 4122 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 2080 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 57241 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 9387 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 8027 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 48320 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 12724 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 2519 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 3764 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 780 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 3358 | 2020-12-30 |
| 2018-10-22 | Class II | Packaging process control | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility | 48320 | 2020-12-30 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19,483 total products | 2020-11-18 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19,483 total products | 2020-11-18 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19,483 total products | 2020-11-18 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19,483 total products | 2020-11-18 |
| 2017-10-03 | Class II | Labeling design | The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications. | 127 | 2018-08-20 |
| 2017-10-03 | Class II | Labeling design | The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications. | 457 | 2018-08-20 |
| 2017-06-05 | Class II | Package design/selection | The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged | 1,517 units | 2019-04-17 |
| 2017-06-05 | Class II | Package design/selection | The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged | 7,888 units | 2019-04-17 |
| 2017-06-05 | Class II | Package design/selection | The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged | 10,116 units | 2019-04-17 |
| 2017-06-05 | Class II | Package design/selection | The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged | 6,290 units | 2019-04-17 |
| 2017-06-05 | Class II | Package design/selection | The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged | 1,631 units | 2019-04-17 |
| 2016-06-27 | Class II | Under Investigation by firm | Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. | 169 | 2017-05-30 |
| 2016-06-27 | Class II | Under Investigation by firm | Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. | 169 | 2017-05-30 |
| 2016-06-27 | Class II | Under Investigation by firm | Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. | 169 | 2017-05-30 |
| 2016-06-27 | Class II | Under Investigation by firm | Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. | 169 | 2017-05-30 |
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.