Kinectiv®
7 catalogue numbers from 00-7848-031-01, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
7catalogue numbers in this listing
9510(k) clearances naming this product code
27recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KWA |
| Device type | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
| Device class | Class 3 |
| Regulation | 21 CFR 888.3330 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K071856 |
| Record published | 2015-09-17 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-7848-031-01 | 12/14 Neck Taper | In distribution |
| 65-7713-013-00 | Size 13.5 | In distribution |
| 00-7848-033-01 | 12/14 Neck Taper | In distribution |
| 00-7848-044-01 | 12/14 Neck Taper | In distribution |
| 00-7848-043-01 | 12/14 Neck Taper | In distribution |
| 00-7848-020-01 | 12/14 Neck Taper | In distribution |
| 00-7848-002-01 | 12/14 Neck Taper | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 48 |
| Conserve® | Microport Orthopedics Inc. | 24 |
| RingLoc+ Hip System | Biomet Orthopedics | 21 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Zimmer, Inc. | 17 |
| Fitmore® Hip Stem | Zimmer, Inc. | 17 |
| Dynasty | Microport Orthopedics Inc. | 12 |
| Asphere | Depuy (Ireland) | 10 |
| Taperloc Complete Micro Primary Femoral | Biomet Orthopedics | 9 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 7 |
| M2A – Modular Head HIP System | Biomet Orthopedics | 6 |
| Transcend® | Microport Orthopedics Inc. | 5 |
| Biolox Delta | Depuy Orthopaedics, Inc. | 4 |
Showing 12 of 20. All products under Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110836 | 2011-10-07 |
| K091003 | 2009-11-24 |
| K091973 | 2009-11-17 |
| K081007 | 2008-05-06 |
| K071723 | 2008-03-07 |
| K071856 | 2007-07-30 |
| K063251 | 2007-01-24 |
| K053536 | 2006-03-16 |
| K850766 | 1985-05-01 |
Recalls Naming This Product
5 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 | 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 96 | 2020-05-28 |
| Zimmer, Inc. | 510(k) number | 2018-05-30 | Class II | Packaging | 24 | 2020-05-28 | |
| Zimmer, Inc. | 510(k) number | 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 116 | 2020-05-28 |
| Zimmer, Inc. | 510(k) number | 2015-05-18 | Class I | Environmental control | Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biolog | 752 | 2016-08-02 |
| Zimmer, Inc. | 510(k) number | 2009-05-29 | Not classified | Packaging process control | The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility. | 147 of both products. | 2009-12-22 |
Recalls
13 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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 194 | 2017-05-23 |
| 2014-12-17 | Class II | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic inf | 16 | 2015-09-23 |
| 2014-12-17 | Class II | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic inf | 30 | 2015-09-23 |
| 2013-08-30 | Class II | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. | 194 (8770-040) | 2014-09-25 |
| 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 | 1190 | 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 | 2011 | 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 | 1739 | 2014-04-16 |
| 2012-07-18 | Class II | Device Design | Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, a | 252 (210 in USA) | 2014-04-17 |
| 2012-07-18 | Class II | Device Design | Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, a | 185 (162 in USA) | 2014-04-17 |
| 2012-07-18 | Class II | Device Design | Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, a | 212 (179 USA) | 2014-04-17 |
| 2012-07-18 | Class II | Device Design | Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, a | 75 (51 in USA) | 2014-04-17 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-07-22 | Not classified | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. | 19,014 of all products. | 2009-10-21 |
| 2008-06-30 | Not classified | Packaging process control | The wrong part may be in the package. Package may contain a 28 mm head. | 4 | 2009-01-05 |
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.