Global CAP CTA
Global C.A.P. CTA CTA Threaded PIN 6 IN
53manufacturers in China registered for this device type
2catalogue numbers in this listing
23recalls 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 | Depuy Orthopaedics, 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 | 2018-09-24 |
| Record revised | 2026-04-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2235-97-001 | In distribution | |
| 2235-90-005 | 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
17 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 |
|---|---|---|---|---|---|
| 2018-09-21 | Class II | Nonconforming Material/Component | There is the potential for debris/material to be found behind the O-rings in the neck trials. | 12639 total | 2020-04-22 |
| 2018-09-21 | Class II | Nonconforming Material/Component | There is the potential for debris/material to be found behind the O-rings in the neck trials. | 12639 total | 2020-04-22 |
| 2018-09-21 | Class II | Nonconforming Material/Component | There is the potential for debris/material to be found behind the O-rings in the neck trials. | 12639 total | 2020-04-22 |
| 2017-07-26 | Class II | Under Investigation by firm | Potential for Intra-operative breakage of driver tips | 130 units total | 2019-04-03 |
| 2017-01-06 | Class II | Vendor change control | Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured. | 345 | 2019-05-15 |
| 2015-09-08 | Class II | Device Design | DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients. | 7488 | 2018-07-03 |
| 2015-02-23 | Class II | Under Investigation by firm | This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient. | 54 of Lot No: SO2018074 | 2015-09-28 |
| 2014-11-12 | Class II | Device Design | Use of excessive force when impacting may lead to intra-operative femoral fracture. | 1130 | 2015-02-24 |
| 2014-11-10 | Class II | Device Design | Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in th | 7,944 | 2015-12-08 |
| 2014-11-10 | Class II | Device Design | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the ins | 4555 | 2015-12-08 |
| 2014-11-10 | Class II | Device Design | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the ins | 4661 | 2015-12-08 |
| 2014-11-10 | Class II | Device Design | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the ins | 3861 | 2015-12-08 |
| 2014-10-15 | Class II | Process control | Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing. | 3,082 | 2015-11-19 |
| 2014-09-03 | Class II | Device Design | Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient. | 875 units | 2015-11-09 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-02-05 | Class II | Device Design | Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure. | 4000; 2600 in USA | 2014-01-06 |
| 2012-03-16 | Not classified | Device Design | DePuy Orthopaedics, Inc. is issuing a Recall Notice for nine lots of the Attune” Impaction Handle due to the potential for the handle trigger to break during surgery. The Attune Impactor is provided as a part of a set of tools and is design | 136 impaction handles | 2014-01-09 |
| 2012-03-12 | Not classified | Packaging process control | Sterility of the pins is at risk because product packaging, which is designed to include 2 pouches (inner pouch and outer pouch) around the pin mounting card only, contains a single pouch, which could compromise product sterility. | 40 of each lot, 120 total | 2013-03-06 |
| 2011-01-12 | Not classified | Other | The firm recieved a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressin | 296 units | 2012-06-27 |
| 2010-10-19 | Not classified | Device Design | The firm was notified that the Hinge Block Femoral Box Guide cut being off alignment when using the S-ROM Distal Femoral Cutting Block Guide SZ SML/X-SML pin holes to locate. The firm then found that the same issue was found int the MED bl | 219 | 2012-12-03 |
| 2010-10-19 | Not classified | Device Design | The firm was notified that the Hinge Block Femoral Box Guide cut being off alignment when using the S-ROM Distal Femoral Cutting Block Guide SZ SML/X-SML pin holes to locate. The firm then found that the same issue was found int the MED bl | 229 | 2012-12-03 |
| 2010-06-15 | Not classified | Process control | Firm discovered that some of their straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring). | 8358 | 2011-11-30 |
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.