Bigliani/Flatow®
69 catalogue numbers from 4300-46-40, listed by Zimmer, Inc., United States, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
69catalogue numbers in this listing
7510(k) clearances naming this product code
20recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K103404 |
| Record published | 2015-09-17 |
| Record revised | 2023-05-03 (version 9) |
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 |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4300-46-40 | 40 mm Diameter Articular Surface | In distribution |
| 4301-52-24 | 24 mm Head Height, 52 mm Spherical Head Diameter | In distribution |
| 4303-46-21 | 21 mm Head Height, 46 mm Spherical Head Diameter | In distribution |
| 4301-56-36 | 36 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4301-01 | In distribution | |
| 4300-56-39 | 39 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4301-46-24 | 24 mm Head Height, 46 mm Spherical Head Diameter | In distribution |
| 4301-38 | In distribution | |
| 4302-46-21 | 21 mm Head Height, 46 mm Spherical Head Diameter | In distribution |
| 00-4303-056-24 | 24 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4301-77-46 | 46 mm Diameter | In distribution |
| 4301-26-52 | 52 mm Glenoid Slot Guide | In distribution |
| 00-4303-056-27 | 27 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4301-52-30 | 30 mm Head Height, 52 mm Spherical Head Diameter | In distribution |
| 4302-40-21 | 21 mm Head Height, 40 mm Spherical Head Diameter | In distribution |
| 4303-52-33 | 33 mm Head Height, 52 mm Spherical Head Diameter | In distribution |
| 8543-01-02 | In distribution | |
| 4303-40-18 | 18 mm Head Height, 40 mm Spherical Head Diameter | In distribution |
| 4302-46-15 | 15 mm Head Height, 46 mm Spherical Head Diameter | In distribution |
| 4301-26-46 | 46 mm Glenoid Slot Guide | In distribution |
| 4301-46-52 | 52 mm Diameter | In distribution |
| 4301-01-10 | In distribution | |
| 4302-46-27 | 27 mm Head Height, 46 mm Spherical Head Diameter | In distribution |
| 4303-52-27 | 27 mm Head Height, 52 mm Spherical Head Diameter | In distribution |
| 00-4307-066-46 | 46 mm Cannulated Straight | In distribution |
| 4300-86 | 46 mm Diameter Articular Surface | In distribution |
| 4301-28-46 | 46 mm Glenoid Reamer | In distribution |
| 4301-29-46 | 46 mm Glenoid Reamer | In distribution |
| 4302-40-46 | 46 mm Diameter Articular Surface | In distribution |
| 4301-27 | In distribution | |
| 4300-85 | 40 mm Diameter Articular Surface | In distribution |
| 00-4307-030-52 | 52 mm Straight | In distribution |
| 4301-30-46 | 46 mm Keeled Glenoid Drill Guide | In distribution |
| 4301-68 | 52 mm Diameter | In distribution |
| 4300-40-46 | 46 mm Diameter Articular Surface | In distribution |
| 4302-46-19 | 19 mm Head Height, 46 mm Spherical Head Diameter | In distribution |
| 00-4303-056-21 | 21 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4303-40-15 | 15 mm Head Height, 40 mm Spherical Head Diameter | In distribution |
| 4302-52-46 | 46 mm Diameter Articular Surface | In distribution |
| 4303-40-24 | 24 mm Head Height, 40 mm Spherical Head Diameter | In distribution |
| 4301-52-27 | 27 mm Head Height, 52 mm Spherical Head Diameter | In distribution |
| 4301-32-46 | 46 mm Keel Sizer/Pressurizer | In distribution |
| 00-4303-056-30 | 30 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4303-75 | In distribution | |
| 4301-40-46 | 46 mm Diameter | In distribution |
| 4301-56-30 | 30 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4301-29-52 | 52 mm Glenoid Reamer With Keel Locator | In distribution |
| 4301-52-56 | 56 mm Diameter | In distribution |
| 4301-46-40 | 40 mm Diameter | In distribution |
| 4300-46-40 | 40 mm Diameter Articular Surface | In distribution |
| 4300-56-42 | 42 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4301-65 | 52 mm Diameter | In distribution |
| 00-4303-056-23 | 23 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4301-66 | 40 mm Diameter | In distribution |
| 4302-46-23 | 23 mm Head Height, 46 mm Spherical Head Diameter | In distribution |
| 4302-40-46 | 46 mm Diameter Articular Surface | In distribution |
| 4303-40-27 | 27 mm Head Height, 40 mm Spherical Head Diameter | In distribution |
| 4303-52-46 | 46 mm Diameter | In distribution |
| 4301-67 | 46 mm Diameter | In distribution |
| 4303-52-19 | 19 mm Head Height, 52 mm Spherical Head Diameter | In distribution |
| 4300-46-33 | 33 mm Head Height, 46 mm Spherical Head Diameter | In distribution |
| 4302-52-33 | 33 mm Head Height, 52 mm Spherical Head Diameter | In distribution |
| 4302-52-56 | 56 mm Diameter Articular Surface | In distribution |
| 4301-64 | 46 mm Diameter | In distribution |
| 00-4303-056-18 | 18 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4301-56-33 | 33 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 4300-40-27 | 27 mm Head Height, 40 mm Spherical Head Diameter | In distribution |
| 00-4303-056-19 | 19 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
| 00-4303-056-33 | 33 mm Head Height, 56 mm Spherical Head Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193180 | 2020-02-24 |
| K191814 | 2019-10-23 |
| K160085 | 2016-03-08 |
| K142403 | 2014-11-24 |
| K062029 | 2006-10-31 |
| K051623 | 2005-07-19 |
| K870262 | 1987-04-03 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 2013-06-11 | Class II | Packaging process control | The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devi | 1 | 2014-01-30 |
| Zimmer, Inc. | 510(k) number | 2012-05-12 | Class II | Mixed-up of materials/components | Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190. | 87 units | 2013-09-12 |
Recalls
11 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 |
|---|---|---|---|---|---|
| 2016-05-17 | Class II | Device Design | In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the | 177 | 2016-10-31 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 45 USA | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 228 | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 224 | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 139 | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 66 | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 26 | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 164 in USA | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 74 | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 260 | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 54 | 2014-04-16 |
| 2007-06-25 | Not classified | Other | The package actually contains a knee patellar implant. | 10 | 2007-12-05 |
| 2005-08-23 | Not classified | Other | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. | 2005-12-08 | |
| 2005-08-23 | Not classified | Other | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. | 2005-12-08 | |
| 2005-08-23 | Not classified | Other | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. | 2005-12-08 | |
| 2005-08-23 | Not classified | Other | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. | 2005-12-08 | |
| 2005-08-23 | Not classified | Other | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. | 2005-12-08 | |
| 2005-08-23 | Not classified | Other | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. | 2005-12-08 | |
| 2005-08-23 | Not classified | Other | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. | 2005-12-08 | |
| 2005-08-23 | Not classified | Other | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. | 2005-12-08 |
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.