NexGen®
15 catalogue numbers from 5970-40-17, listed by Zimmer, Inc., United States, under Sterilizer, Chemical. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Incote Precision Machinery Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 2 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | MLR |
| Device type | Sterilizer, Chemical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6860 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K173057 |
| Record published | 2015-09-17 |
| Record revised | 2019-08-19 (version 7) |
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 |
| Sizes | Height 9 to 20 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5970-40-17 | Size Green | In distribution |
| 5970-21-17 | Height 17 mm | In distribution |
| 5970-21-20 | Size Striped Purple | In distribution |
| 5970-30-14 | Height 14 mm | In distribution |
| 5970-50-09 | Size Blue, (5.5 mm Under the Condyles) | In distribution |
| 5970-40-09 | Size Green, (5.5 mm Under the Condyles) | In distribution |
| 5970-30-10 | Size Yellow | In distribution |
| 5970-30-17 | Size Yellow | In distribution |
| 5970-21-09 | Size Striped Purple, (5.5 mm Under the Condyles) | In distribution |
| 5970-30-09 | Size Yellow, (5.5 mm Under the Condyles) | In distribution |
| 5970-40-20 | Size Green | In distribution |
| 5970-50-12 | Height 12 mm | In distribution |
| 5970-21-14 | Size Striped Purple | In distribution |
| 5970-50-20 | Height 20 mm | In distribution |
| 5970-50-14 | Height 14 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trilogy® | Zimmer, Inc. | 274 |
| Sterrad™ | Advanced Sterilization Products Services Inc. | 18 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 10 |
| V-PRO | Steris Mexico, S. de R.L. de C.V. | 7 |
| Amsco V-PRO | Steris Mexico, S. de R.L. de C.V. | 6 |
| SteroScope Insert Connector Large Assembly, Type 3, Qty 1 | Ideate Medical | 4 |
| Vaprox | Steris Corporation | 4 |
| Sterilink™ | Plasmapp Co., Ltd. | 3 |
| SteroScope Insert Connector Extra Small Assembly, Type R2, Qty 1 | Ideate Medical | 2 |
| Sterlink™ | Plasmapp Co., Ltd. | 2 |
| SteroScope Biopsy Connector Assembly, Type R1, Qty 1 | Ideate Medical | 2 |
| Sterrad NX™ | Advanced Sterilization Products Services Inc. | 2 |
Showing 12 of 34. All products under Sterilizer, Chemical
Recalls Naming This Product
90 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 | 2023-05-19 | Class II | Under Investigation by firm | Device outer packaging was incorrectly labeled. | 2026-05-29 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1673 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2092 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2460 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1366 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1049 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 284 | |
| 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. | 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 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. | 49 | 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. | 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. | 29525 | 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 | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2012-09-21 | Class II | Process change control | Zimmer is initiating a lot specific recall of the NexGen Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a resu | 123 worldwide (33 USA) | 2014-04-17 |
| 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 90.
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.