Specialty DSA Retractor Pin
Catalogue number I-H2171RP00, listed by Howmedica Osteonics Corp, 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
1catalogue number
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 | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-09-07 |
| Record revised | 2021-09-23 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-H2171RP00 | 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
15 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 |
|---|---|---|---|---|---|
| 2024-05-23 | Class II | Device Design | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization | 209 units | |
| 2024-05-23 | Class II | Device Design | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization | 630 units | |
| 2023-12-22 | Class II | Package design/selection | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility | ||
| 2023-12-22 | Class II | Package design/selection | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility | ||
| 2023-05-03 | Class II | Under Investigation by firm | The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head. | 2 units | |
| 2018-09-10 | Class II | Under Investigation by firm | Potential for outer pouch sterile barrier to be compromised | 15 pouches | 2020-08-31 |
| 2016-12-02 | Class II | Device Design | Reunion TSA Peg Alignment Sound broke during surgery. | 131 units | 2018-08-01 |
| 2014-05-01 | Class II | Process control | Tritanium Patella Inserter Instrument fracture during implantation. . | 22 Units | 2017-06-09 |
| 2013-11-20 | Class II | Process design | Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle. | 211 units | 2016-10-13 |
| 2013-01-24 | Class II | Process design | The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the “R” and “L” markings on the Right Sizer are reversed. | 4 units (total of 2 sets) | 2015-05-06 |
| 2012-12-20 | Class II | Process control | Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. | 48 units | 2015-09-30 |
| 2012-08-06 | Class II | Nonconforming Material/Component | During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube. | 100 units (73 units US; 27 units OUS) | 2013-09-11 |
| 2012-07-27 | Class II | Error in labeling | Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational marki | 7 units | 2015-09-30 |
| 2012-07-27 | Class II | Error in labeling | Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational marki | 8 | 2015-09-30 |
| 2011-12-22 | Class II | Nonconforming Material/Component | Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was later determined to | 152 units | 2013-06-13 |
| 2011-11-17 | Not classified | Nonconforming Material/Component | Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer. | five units | 2012-12-19 |
| 2011-10-10 | Not classified | Device Design | Stryker received a Product Experience Report (PER) that a swivel block was improperly oriented on a Triathlon Tibial Alignment Handle, catalog no. 6541-2-807. | 6,126 Units | 2014-09-10 |
| 2011-08-19 | Not classified | Process control | Stryker Orthopaedics has become ware that there is the potential for the above referenced instruments to fracture in two pieces along the width of the body under the striking plate. | 106 UNITS | 2017-07-11 |
| 2010-11-01 | Not classified | Device Design | The CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach Handle may fracture in two pieces along the width of the body under the striking plate. This may extend surgical time under anesthesia, c | 459 units | 2014-03-26 |
| 2010-09-27 | Not classified | Device Design | Stryker Orthopaedics has become aware that there is a potential for the shoulder screw on the Scorpio Sizing Guide (the “Sizing Guide”) to disassociate from the main body of the instrument. | six units | 2013-07-31 |
| 2010-09-27 | Not classified | Device Design | Stryker Orthopaedics has become aware that there is a potential for the shoulder screw on the Scorpio Sizing Guide (the “Sizing Guide”) to disassociate from the main body of the instrument. | 237 units | 2013-07-31 |
| 2010-08-23 | Not classified | Device Design | Stryker has received reports in which the Cutting Blocks have fractured on impaction during surgery. | 2012-08-30 | |
| 2010-08-23 | Not classified | Device Design | Stryker has received reports in which the Cutting Blocks have fractured on impaction during surgery. | 839 units (total) | 2012-08-30 |
| 2010-08-23 | Not classified | Device Design | Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery. | 839 (total) | 2012-08-30 |
| 2010-08-23 | Not classified | Device Design | Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery. | 839 (total) | 2012-08-30 |
| 2010-08-23 | Not classified | Device Design | Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery. | 839 (total) | 2012-08-30 |
| 2010-08-23 | Not classified | Device Design | Stryker has received reports in which the Cutting Blocks have fractured on impaction during surgery. | 839 (total) | 2012-08-30 |
| 2010-08-23 | Not classified | Device Design | Stryker has received reports in which the Cutting Blocks have fractured on impaction during surgery. | 839 units (total) | 2012-08-30 |
| 2010-08-23 | Not classified | Device Design | Stryker has received reports in which the Cutting Blocks have fractured on impaction during surgery. | 2012-08-30 | |
| 2010-08-23 | Not classified | Device Design | Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery. | 839 (total) | 2012-08-30 |
| 2010-07-13 | Not classified | Other | Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of.024″ (0.6mm). | 159,095. all types | 2017-09-29 |
| 2010-07-13 | Not classified | Other | Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of.024″ (0.6mm). | 159, 095 units, all types | 2017-09-29 |
| 2010-07-13 | Not classified | Other | Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of.024″ (0.6mm). | 159,095 all types | 2017-09-29 |
| 2010-04-05 | Not classified | Device Design | The locating pins on the Punch Thru Tibial Baseplates could break or disassociate from the main body of the instrument. | 8276 | 2012-08-28 |
| 2010-04-05 | Not classified | Device Design | There is the potential for the posts on the Distal Resection Guide Stand to disassociate from the main body part. | 676 in US, 1305 internationally. | 2012-08-28 |
| 2010-04-05 | Not classified | Device Design | One of the two posts on the Anterior Resection Guide could disassociate from the main body of the part which has been determined to be caused by a fracture weld. | 682 units in US, 1292 units internationally. | 2012-08-28 |
| 2009-12-03 | Not classified | Device Design | The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block. | 9833 Scorpio Cutting Blocks, total | 2012-09-14 |
| 2009-12-03 | Not classified | Device Design | The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block. | 9833 Scorpio Cutting Blocks, total | 2012-09-14 |
| 2009-12-03 | Not classified | Device Design | The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block. | 9833 Scorpio Cutting Blocks, total | 2012-09-14 |
| 2009-12-03 | Not classified | Device Design | The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block. | 3056 Duracon Cutting Blocks, total | 2012-09-14 |
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.