Fitmore® Hip Stem
Fitmore Hip Stem A, Size 10
4manufacturers in China registered for this device type
17catalogue 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 |
| Record published | 2016-11-07 |
| Record revised | 2018-03-29 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.00551.110 | 10 | In distribution |
| 01.00551.403 | 3 | In distribution |
| 01.00551.104 | 4 | In distribution |
| 01.00551.112 | 12 | In distribution |
| 01.00551.107 | 7 | In distribution |
| 01.00551.402 | 2 | In distribution |
| 01.00551.208 | 8 | In distribution |
| 01.00551.108 | 8 | In distribution |
| 01.00551.202 | 2 | In distribution |
| 01.00551.110 | 10 | In distribution |
| 01.00551.214 | B/14, taper 12/14 | In distribution |
| 01.00551.209 | 9 | In distribution |
| 01.00551.109 | 9 | In distribution |
| 01.00551.105 | 5 | In distribution |
| 01.00551.201 | 1 | In distribution |
| 01.00551.203 | 3 | In distribution |
| 01.00551.109 | 9 | 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 |
| 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 |
| Kinectiv® | Zimmer, Inc. | 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
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
| 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 |
| 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.