Tornier Latitude
Diaphysis Drilling Guide Handle
53manufacturers in China registered for this device type
120catalogue numbers in this listing
3recalls 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 | Tornier 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, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-08 |
| Record revised | 2024-04-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 41 to 200 mm; outer diameter 5 to 6.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MKY091 | Size LARGE | In distribution |
| MKY139 | Size LARGE + | In distribution |
| MKY096 | Size MEDIUM | In distribution |
| 9030306 | Size LARGE | In distribution |
| 9030286 | Size SMALL | In distribution |
| 9030083 | Length 150 mm | In distribution |
| 9030102 | Length 150 mm | In distribution |
| MKY125 | Size SMALL | In distribution |
| 9030280 | Size SMALL | In distribution |
| MKY105 | Size MEDIUM | In distribution |
| 9030104 | Length 200 mm | In distribution |
| 9030291 | Size MEDIUM | In distribution |
| MKY080 | Size SMALL | In distribution |
| 9030292 | Length 75 mm | In distribution |
| 9030284 | Size SMALL | In distribution |
| 9030095 | Size MEDIUM | In distribution |
| MKY082 | Size MEDIUM | In distribution |
| MKY112 | Size LARGE | In distribution |
| MKY094 | Size LARGE | In distribution |
| MKY142 | Size LARGE + | In distribution |
| MKY083 | Size MEDIUM | In distribution |
| MKY140 | Size LARGE + | In distribution |
| MKY086 | Size SMALL | In distribution |
| MKY134 | Size LARGE + | In distribution |
| 9030307 | Length 150 mm | In distribution |
| 9030015 | Size LARGE | In distribution |
| MKY109 | Size MEDIUM | In distribution |
| 9030282 | Length 70 mm | In distribution |
| 9030005 | Size LARGE | In distribution |
| MKY116 | Outer Diameter 5 mm | In distribution |
| 9030094 | Length 200 mm | In distribution |
| MKY149 | In distribution | |
| MKY115 | Size LARGE | In distribution |
| MKY103 | Size LARGE | In distribution |
| MKY130 | Size LARGE | In distribution |
| MKY099 | Size MEDIUM | In distribution |
| 9030084 | Size SMALL | In distribution |
| MKY087 | Size MEDIUM | In distribution |
| MKY088 | Size LARGE | In distribution |
| 9030007 | Size LARGE + | In distribution |
| MKY141 | Size LARGE + | In distribution |
| MKY095 | Size SMALL | In distribution |
| 9030340 | Size SMALL | In distribution |
| MKY089 | Size SMALL | In distribution |
| MKY107 | Size SMALL | In distribution |
| MKY111 | Size LARGE | In distribution |
| MKY117 | Outer Diameter 6.5 mm | In distribution |
| 9030283 | Length 70 mm | In distribution |
| 9030011 | Size SMALL | In distribution |
| 9030010 | Size SMALL | In distribution |
| 9030287 | Length 150 mm | In distribution |
| 9030091 | Size MEDIUM | In distribution |
| MKY090 | Size MEDIUM | In distribution |
| 9030304 | Size LARGE | In distribution |
| 9030085 | Size SMALL | In distribution |
| MKY126 | Size SMALL | In distribution |
| MKY108 | Size SMALL | In distribution |
| 9030290 | Size MEDIUM | In distribution |
| 9030303 | Size LARGE | In distribution |
| MKY104 | Size SMALL | In distribution |
| 9030301 | Length 52 mm | In distribution |
| MKY048 | In distribution | |
| 9030293 | Length 75 mm | In distribution |
| 9030305 | Length 125 mm | In distribution |
| 9030003 | Size MEDIUM | In distribution |
| 9030297 | Size MEDIUM | In distribution |
| MKY102 | Size MEDIUM | In distribution |
| MKY127 | Size MEDIUM | In distribution |
| 9030355 | Size LARGE + | In distribution |
| 9030345 | Size MEDIUM | In distribution |
| MKY106 | Size LARGE | In distribution |
| MKY121 | In distribution | |
| 9030101 | Length 83 mm | In distribution |
| MKY118 | In distribution | |
| MKY114 | Size MEDIUM | In distribution |
| MKY055 | Size SMALL | In distribution |
| 9030093 | Length 150 mm | In distribution |
| 9030016 | Size LARGE + | In distribution |
| 9030210 | In distribution | |
| MKY100 | Size LARGE | In distribution |
| MKY084 | Size LARGE | In distribution |
| MKY113 | Size SMALL | In distribution |
| 9030105 | Size LARGE | In distribution |
| MKY097 | Size LARGE | In distribution |
| 9030080 | Size SMALL | In distribution |
| MKY092 | Size SMALL | In distribution |
| 9030115 | In distribution | |
| MKY143 | Size LARGE + | In distribution |
| MCI511 | In distribution | |
| MKY110 | Size MEDIUM | In distribution |
| 9030081 | Size SMALL | In distribution |
| 9030082 | Size SMALL | In distribution |
| 9030013 | Size MEDIUM | In distribution |
| 9030135 | In distribution | |
| MKY144 | Size LARGE + | In distribution |
| MKY128 | Size MEDIUM | In distribution |
| 9030300 | Length 52 mm | In distribution |
| 9030100 | Length 83 mm | In distribution |
| 9030295 | Length 125 mm | In distribution |
| MKY085 | Size LARGE | In distribution |
| 9030092 | Length 150 mm | In distribution |
| MKY081 | Size SMALL | In distribution |
| 9030014 | Size LARGE | In distribution |
| MKY057 | Size LARGE | In distribution |
| 9030281 | Length 41 mm | In distribution |
| MKY093 | Size MEDIUM | In distribution |
| 9030001 | Size SMALL | In distribution |
| MKY101 | Size SMALL | In distribution |
| 9030285 | Size SMALL | In distribution |
| 9030090 | Size MEDIUM | In distribution |
| 9030350 | Size LARGE | In distribution |
| MKY098 | Size SMALL | In distribution |
| 9030103 | Size LARGE | In distribution |
| 9030296 | Length 150 mm | In distribution |
| 9030017 | Size LARGE + | In distribution |
| 9030294 | Length 125 mm | In distribution |
| 9030302 | Length 80 mm | In distribution |
| MKY056 | Size MEDIUM | In distribution |
| 9030012 | Size MEDIUM | In distribution |
| MKY129 | Size LARGE | 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Tornier Inc. | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. ” Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) ” Device Actually: 9030092, Humeral Stem Trial 150mm M | 5 units |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2022-05-03 | Class II | Device Design | The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container. | 1066 units | |
| 2014-09-19 | Class II | Device Design | Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer | 38 | 2016-10-31 |
| 2009-10-16 | Not classified | Other | The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and k | 127 pieces | 2012-04-11 |
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.