NexGen® Legacy®
33 catalogue numbers from 00-5961-013-91, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
33catalogue numbers in this listing
19510(k) clearances naming this product code
29recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| 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 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K031061 |
| Record published | 2016-05-24 |
| Record revised | 2022-03-22 (version 7) |
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 |
|---|---|---|
| 00-5961-013-91 | Size C | In distribution |
| 5992-12-01 | Size B | In distribution |
| 00-5962-014-51 | Size D | In distribution |
| 00-5962-015-52 | Size E | In distribution |
| 00-5762-013-51 | Size C | In distribution |
| 00-5961-018-82 | Size H | In distribution |
| 00-5961-013-82 | Size C | In distribution |
| 00-5961-017-81 | Size G | In distribution |
| 00-5961-018-81 | Size H | In distribution |
| 00-5762-015-51 | Size E | In distribution |
| 00-5762-016-51 | Size F | In distribution |
| 00-5962-015-51 | Size E | In distribution |
| 00-5762-014-52 | Size D | In distribution |
| 00-5961-015-81 | Size E | In distribution |
| 00-5961-015-91 | Size E | In distribution |
| 00-5962-012-51 | Size B | In distribution |
| 00-5762-016-52 | Size F | In distribution |
| 00-5961-016-91 | Size F | In distribution |
| 00-5962-014-52 | Size D | In distribution |
| 00-5962-017-51 | Size G | In distribution |
| 00-5762-013-52 | Size C | In distribution |
| 00-5762-015-52 | Size E | In distribution |
| 00-5961-017-82 | Size G | In distribution |
| 00-5961-016-92 | Size F | In distribution |
| 00-5961-015-82 | Size E | In distribution |
| 00-5762-017-52 | Size G | In distribution |
| 5992-12-02 | Size B | In distribution |
| 5992-13-02 | Size C | In distribution |
| 00-5961-017-91 | Size G | In distribution |
| 5992-15-02 | Size E | In distribution |
| 00-5962-013-52 | Size C | In distribution |
| 00-5762-017-51 | Size G | In distribution |
| 00-5961-014-82 | Size D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251840 | 2026-05-28 |
| K253189 | 2026-03-09 |
| K242543 | 2024-11-22 |
| K243247 | 2024-10-29 |
| K240299 | 2024-04-26 |
| K222566 | 2022-10-17 |
| K172524 | 2018-05-17 |
| K173417 | 2018-01-30 |
| K150090 | 2015-05-20 |
| K141840 | 2014-09-03 |
| K123459 | 2013-02-22 |
| K122745 | 2012-12-05 |
| K121771 | 2012-11-07 |
| K072619 | 2007-11-21 |
| K072160 | 2007-09-05 |
| K071107 | 2007-07-06 |
| K070214 | 2007-03-16 |
| K041100 | 2004-10-29 |
| K031061 | 2003-10-09 |
Recalls Naming This Product
103 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 | 2024-03-28 | Class II | Process change control | Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. | 5,546 units | |
| Zimmer, Inc. | 510(k) number | 2023-05-19 | Class II | Under Investigation by firm | Device outer packaging was incorrectly labeled. | 2026-05-29 | |
| 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 | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 2020-04-02 | |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorr | 24 | 2018-07-03 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 32508 | 2017-05-23 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 18482 | 2017-05-23 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 53338 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 202221 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 39 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2015-12-03 | Class II | Labeling mix-ups | A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3. | 384 distribution events; 1 unit was returned leaving 383 uni | 2016-09-15 |
| Zimmer Manufacturing B.V. | 510(k) number | 2015-12-02 | Class II | Packaging | Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264 | 179 | 2016-09-16 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations faile | 972,125 units | 2015-09-15 |
| Zimmer, Inc. | 510(k) number | 2013-10-31 | Class II | Device Design | Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose | 128 units | 2015-04-30 |
| Zimmer, Inc. | 510(k) number | 2012-04-30 | Class II | Component design/selection | The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off | 1662 units | 2014-06-04 |
| Zimmer, Inc. | 510(k) number | 2012-04-30 | Class II | Component design/selection | The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off | 65 units | 2014-06-04 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
Showing 40 of 103.
Recalls
7 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 |
|---|---|---|---|---|---|
| 2026-05-11 | Class II | Labeling Change Control | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. | 12 | |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2016-05-11 | Class II | Component design/selection | Zimmer Inc. is initiating a recall of specific Persona” Trabecular Metal” Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants. | 10,256 | 2017-06-02 |
| 2015-01-28 | Class II | Under Investigation by firm | An increase in complaints of loosening and radiolucent lines. | 11,658 | 2018-03-13 |
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.