Screw, Fixation, Bone
2.7MM TI Cortex Screw SLF-Tpng With T8 Stardrive Recess 20MM
31manufacturers in China registered for this device type
3,975catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K043185 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (version 12) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-07-10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 04.200.012 | In distribution | ||
| 456.328S | In distribution | ||
| 04.172.630SHA | In distribution | ||
| 04.501.430.01 | In distribution | ||
| 02.227.300 | In distribution | ||
| 408.945 | In distribution | ||
| 02.150.460 | In distribution | ||
| 04.226.770S | In distribution | ||
| 414.564 | In distribution | ||
| 02.170.640SHA | In distribution | ||
| 04.226.034 | In distribution | ||
| 209.885 | In distribution | ||
| 402.880 | In distribution | ||
| 02.111.160S | In distribution | ||
| 218.018 | In distribution | ||
| 02.206.255 | In distribution | ||
| 04.226.226 | In distribution | ||
| 04.227.055 | In distribution | ||
| 209.850 | In distribution | ||
| 02.226.232 | In distribution | ||
| 204.034 | In distribution | ||
| 02.226.130 | In distribution | ||
| 456.355S | In distribution | ||
| 02.206.240S | In distribution | ||
| 02.211.403S | In distribution | ||
| 02.221.460 | In distribution | ||
| 04.111.205 | In distribution | ||
| 02.221.510 | In distribution | ||
| 208.945 | In distribution | ||
| 458.990S | In distribution | ||
| 02.227.075 | In distribution | ||
| 204.030 | In distribution | ||
| 408.438 | In distribution | ||
| 02.210.096 | In distribution | ||
| 202.720 | In distribution | ||
| 212.323 | In distribution | ||
| 404.834 | In distribution | ||
| 204.725 | In distribution | ||
| 402.884 | In distribution | ||
| 02.206.295S | In distribution | ||
| 408.408 | In distribution | ||
| 02.221.508S | In distribution | ||
| 209.095 | In distribution | ||
| 400.740E | In distribution | ||
| 04.211.408S | In distribution | ||
| 04.226.326S | In distribution | ||
| 02.227.085S | In distribution | ||
| 202.878 | In distribution | ||
| 211.849 | In distribution | ||
| 02.226.630 | In distribution | ||
| 211.818 | In distribution | ||
| 02.150.415S | In distribution | ||
| 218.012 | In distribution | ||
| 02.200.140 | In distribution | ||
| 406.080 | In distribution | ||
| 208.419 | In distribution | ||
| 408.414 | In distribution | ||
| 456.498S | In distribution | ||
| 04.214.105 | In distribution | ||
| 02.227.105 | In distribution | ||
| 202.615 | In distribution | ||
| 246.031 | In distribution | ||
| 408.450 | In distribution | ||
| 04.211.213S | In distribution | ||
| 407.648 | In distribution | ||
| SD211.110 | In distribution | ||
| 205.020 | In distribution | ||
| 206.456 | In distribution | ||
| 208.441 | In distribution | ||
| 04.005.518 | In distribution | ||
| 458.980 | In distribution | ||
| 04.045.062 | In distribution | ||
| 04.045.550S | In distribution | ||
| 02.226.325 | In distribution | ||
| 206.418 | In distribution | ||
| 04.228.511TS | In distribution | ||
| 04.226.638 | In distribution | ||
| 208.950 | In distribution | ||
| 209.755 | In distribution | ||
| 04.043.475S | In distribution | ||
| 02.230.110 | In distribution | ||
| 407.055 | In distribution | ||
| 02.206.052S | In distribution | ||
| 02.206.065 | In distribution | ||
| 409.660 | In distribution | ||
| 04.152.455S | In distribution | ||
| 02.221.518 | In distribution | ||
| 02.230.114S | In distribution | ||
| 04.226.321 | In distribution | ||
| 208.915 | In distribution | ||
| SD292.680 | In distribution | ||
| 04.130.111 | In distribution | ||
| 04.206.222 | In distribution | ||
| 02.210.146 | In distribution | ||
| 04.226.652S | In distribution | ||
| 205.244 | In distribution | ||
| 207.612 | In distribution | ||
| 216.035 | In distribution | ||
| 406.422 | In distribution | ||
| 04.210.142 | In distribution | ||
| 02.206.075S | In distribution | ||
| 205.048 | In distribution | ||
| 208.055 | In distribution | ||
| 04.043.305S | In distribution | ||
| 209.950 | In distribution | ||
| 02.227.085 | In distribution | ||
| 04.045.254 | In distribution | ||
| 02.130.320 | In distribution | ||
| 02.211.413S | In distribution | ||
| 04.043.535S | In distribution | ||
| 03.111.037 | In distribution | ||
| 216.050 | In distribution | ||
| 02.118.560 | In distribution | ||
| 02.204.044 | In distribution | ||
| 204.085 | In distribution | ||
| 02.206.060S | In distribution | ||
| 02.227.285S | In distribution | ||
| 02.210.107 | In distribution | ||
| 02.230.117S | In distribution | ||
| 201.774 | In distribution | ||
| 02.226.732 | In distribution | ||
| 04.045.072S | In distribution | ||
| 04.210.098 | In distribution | ||
| 02.226.221S | In distribution | ||
| 04.005.444 | In distribution | ||
| 456.491S | In distribution | ||
| 04.005.468S | In distribution | ||
| 04.252.655 | In distribution | ||
| 294.788SHA | In distribution | ||
| 04.043.135S | In distribution | ||
| 408.405 | In distribution | ||
| 02.210.158 | In distribution | ||
| 04.045.562 | In distribution | ||
| 408.478 | In distribution | ||
| 04.228.515TS | In distribution | ||
| 04.226.329 | In distribution | ||
| 414.520 | In distribution | ||
| 02.226.029 | In distribution | ||
| 456.460S | In distribution | ||
| 214.150 | In distribution | ||
| 02.206.266 | In distribution | ||
| 04.005.470 | In distribution | ||
| 04.005.638S | In distribution | ||
| 04.111.220S | In distribution | ||
| 04.045.100 | In distribution | ||
| 02.200.060 | In distribution | ||
| 416.040 | In distribution | ||
| 04.045.222S | In distribution | ||
| 02.150.420 | In distribution | ||
| 02.226.321 | In distribution | ||
| 214.776 | In distribution | ||
| 212.321 | In distribution | ||
| 02.206.236S | In distribution | ||
| 02.207.275 | In distribution | ||
| 208.910 | In distribution | ||
| 407.095 | In distribution | ||
| 408.435 | In distribution | ||
| 458.948S | In distribution | ||
| 208.461 | In distribution | ||
| 02.231.228 | In distribution | ||
| 209.855 | In distribution | ||
| 04.111.195S | In distribution | ||
| 04.045.538TS | In distribution | ||
| 02.206.060 | In distribution | ||
| 02.206.264S | In distribution | ||
| 04.226.232S | In distribution | ||
| 02.211.022 | In distribution | ||
| 04.230.115S | In distribution | ||
| 212.317 | In distribution | ||
| 214.580 | In distribution | ||
| 04.043.505S | In distribution | ||
| 04.170.625 | In distribution | ||
| 02.206.250 | In distribution | ||
| 414.580 | In distribution | ||
| 201.044 | In distribution | ||
| 02.226.209S | In distribution | ||
| 02.130.312 | In distribution | ||
| 02.210.088 | In distribution | ||
| 458.946S | In distribution | ||
| 02.206.048 | In distribution | ||
| 04.227.100 | In distribution | ||
| 04.200.034 | In distribution | ||
| 04.226.700 | In distribution | ||
| 04.005.546 | In distribution | ||
| 456.415S | In distribution | ||
| 214.736 | In distribution | ||
| 216.085 | In distribution | ||
| 406.442 | In distribution | ||
| 04.210.116TS | In distribution | ||
| 02.207.617 | In distribution | ||
| 200.818 | In distribution | ||
| 209.150 | In distribution | ||
| 204.836 | In distribution | ||
| 406.440 | In distribution | ||
| 408.486 | In distribution | ||
| 02.250.585SHA | In distribution | ||
| 02.172.625S | In distribution | ||
| 205.236 | In distribution | ||
| 02.226.227 | In distribution | ||
| 04.118.558 | In distribution | ||
| 02.206.210S | In distribution | ||
| 211.819 | In distribution | ||
| 04.045.554S | In distribution | ||
| 456.451S | In distribution | ||
| 04.226.754S | In distribution | ||
| 04.005.556S | In distribution | ||
| 04.226.320S | In distribution | ||
| 209.905 | In distribution | ||
| 418.018 | In distribution | ||
| 218.017 | In distribution | ||
| 205.028 | In distribution | ||
| 02.210.112TS | In distribution | ||
| 04.045.356S | In distribution | ||
| 02.207.627 | In distribution | ||
| 04.226.732 | In distribution | ||
| 04.211.224S | In distribution | ||
| 497.668 | 5 | In distribution | |
| 04.005.646 | In distribution | ||
| 02.111.240 | In distribution | ||
| 04.045.356 | In distribution | ||
| 04.210.122TS | In distribution | ||
| 02.227.345 | In distribution | ||
| 214.816 | In distribution | ||
| 408.410 | In distribution | ||
| 02.130.153S | In distribution | ||
| 202.613 | In distribution | ||
| 402.210 | In distribution | ||
| 408.402 | In distribution | ||
| 456.302S | In distribution | ||
| 04.233.448S | In distribution | ||
| 04.227.135S | In distribution | ||
| 456.446S | In distribution | ||
| 458.926S | In distribution | ||
| 02.111.190 | In distribution | ||
| 04.226.327S | In distribution | ||
| 04.045.326 | In distribution | ||
| 02.111.160 | In distribution | ||
| 04.233.428S | In distribution | ||
| 02.211.034 | In distribution | ||
| 04.200.046 | In distribution | ||
| 201.020 | In distribution | ||
| 458.932 | In distribution | ||
| SD211.100 | In distribution | ||
| 04.045.548TS | In distribution | ||
| 04.130.161S | In distribution | ||
| 04.226.795 | In distribution | ||
| 209.430 | In distribution | ||
| 02.226.228S | In distribution | ||
| 04.130.150 | In distribution | ||
| 02.226.211S | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
| Volt | Synthes Gmbh | 1,444 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
Recalls Naming This Product
48 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2025-09-26 | Class II | Process control | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. | 120 units | |
| Synthes (USA) Products LLC | 510(k) number | 2025-09-26 | Class II | Process control | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. | 122 units | |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes (USA) Products LLC | 510(k) number | 2018-09-12 | Class II | Under Investigation by firm | The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length. | 20 | 2020-04-10 |
| Microport Orthopedics Inc. | 510(k) number | 2017-09-18 | Class II | Packaging process control | The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infec | 48 units | 2021-04-08 |
| Synthes (USA) Products LLC | 510(k) number | 2017-07-21 | Class II | Employee error | The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot. | 4 units | 2018-07-10 |
| Synthes (USA) Products LLC | 510(k) number | 2016-06-28 | Class II | Nonconforming Material/Component | It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leav | 41 units | 2017-02-02 |
| Synthes (USA) Products LLC | 510(k) number | 2016-04-04 | Class II | Process control | This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date. | 15 units | 2016-09-02 |
| Synthes (USA) Products LLC | 510(k) number | 2016-02-16 | Class II | Labeling False and Misleading | Labeling does not match the cleared indications for use in the United States and Canada. | 19,497,844 units in total | 2017-06-01 |
| Synthes (USA) Products LLC | 510(k) number | 2016-02-16 | Class II | Labeling False and Misleading | Labeling does not match the cleared indications for use in the United States and Canada. | 19,497,844 units in total | 2017-06-01 |
| Synthes (USA) Products LLC | 510(k) number | 2016-02-16 | Class II | Labeling False and Misleading | Labeling does not match the cleared indications for use in the United States and Canada. | 19,497,844 units in total | 2017-06-01 |
| Synthes (USA) Products LLC | 510(k) number | 2016-02-16 | Class II | Labeling False and Misleading | Labeling does not match the cleared indications for use in the United States and Canada. | 19,497,844 units in total | 2017-06-01 |
| Synthes (USA) Products LLC | 510(k) number | 2016-02-16 | Class II | Labeling False and Misleading | Labeling does not match the cleared indications for use in the United States and Canada. | 19,497,844 units in total | 2017-06-01 |
| Synthes (USA) Products LLC | 510(k) number | 2016-02-16 | Class II | Labeling False and Misleading | Labeling does not match the cleared indications for use in the United States and Canada. | 19,497,844 units in total | 2017-06-01 |
| Synthes (USA) Products LLC | 510(k) number | 2016-02-16 | Class II | Labeling False and Misleading | Labeling does not match the cleared indications for use in the United States and Canada. | 19,497,844 units in total | 2017-06-01 |
| Synthes (USA) Products LLC | 510(k) number | 2015-11-02 | Class II | Process control | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP | 229 | 2016-07-15 |
| Synthes (USA) Products LLC | 510(k) number | 2015-11-02 | Class II | Process control | TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or | 5 | 2016-05-13 |
| Synthes (USA) Products LLC | 510(k) number | 2015-10-06 | Class II | Packaging | Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. | 98 | 2016-07-15 |
| Synthes (USA) Products LLC | 510(k) number | 2015-09-28 | Class II | Labeling mix-ups | The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S | 36 | 2016-12-06 |
| Synthes (USA) Products LLC | 510(k) number | 2015-07-29 | Class II | Labeling design | Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR | 5306080 | 2016-09-27 |
| Synthes Gmbh | 510(k) number | 2015-05-13 | Class II | Employee error | Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly. | 54 | 2016-08-18 |
| Synthes Gmbh | 510(k) number | 2014-10-29 | Class II | Employee error | The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction an | 6 | 2015-12-18 |
| Synthes Gmbh | 510(k) number | 2014-06-30 | Class II | Employee error | A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic. | 4 | 2015-12-18 |
| Synthes Gmbh | 510(k) number | 2014-04-10 | Class II | Labeling Change Control | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. | 5,114,052 | 2016-08-26 |
| Synthes Gmbh | 510(k) number | 2014-02-05 | Class II | Employee error | Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert). | 45 | 2015-08-31 |
| Synthes Gmbh | 510(k) number | 2014-01-07 | Class II | Component design/selection | The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the D | 343 | 2015-09-10 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-10-03 | Class II | Process control | A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed. | 350195 | 2016-08-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-31 | Class II | Labeling mix-ups | Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw. | 98 | 2016-08-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-31 | Class II | Process control | The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. | 135 | 2015-06-01 |
| Synthes (USA) Products LLC | 510(k) number | 2013-07-30 | Class II | Labeling mix-ups | A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. | 13 | 2015-08-17 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-30 | Class II | Nonconforming Material/Component | Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail. | 17 | 2015-09-10 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-30 | Class II | Employee error | Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging. | 12 | 2015-09-10 |
| Synthes (USA) Products LLC | 510(k) number | 2013-05-31 | Class II | Device Design | The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Var | 119, 891 | 2015-09-21 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-05-29 | Class II | Employee error | A plate was inadvertently released to a sales consultant that was restricted for sale. | 1 | 2015-05-21 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-03-08 | Class II | Labeling design | A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for sup | 62 | 2015-08-12 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-03-08 | Class II | Labeling mix-ups | Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). | 2 | 2015-05-21 |
Showing 40 of 48.
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2014-05-15 | Class II | Labeling design | All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label. | 44 | 2015-12-18 |
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.