Trident
190 catalogue numbers from 621-00-28J, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
190catalogue numbers in this listing
16510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 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 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K983382 |
| Record published | 2015-09-24 |
| Record revised | 2026-07-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Lumen/inner diameter 22 to 44 mm; outer diameter 40 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 621-00-28J | Alpha Code: J | In distribution |
| 623-00-26H | Lumen/Inner Diameter 26.0 mm | In distribution |
| 663-00-36G | Lumen/Inner Diameter 36.0 mm | In distribution |
| 621-10-32I | Alpha Code: I | In distribution |
| 509-02-74J | Outer Diameter 74.0 mm | In distribution |
| 623-00-22A | Lumen/Inner Diameter 22.0 mm | In distribution |
| 540-11-54F | Outer Diameter 54.0 mm | In distribution |
| 542-01-58G | Alpha Code: G | In distribution |
| 661-00-32F | Alpha Code: F | In distribution |
| 542-01-42B | Outer Diameter 42.0 mm | In distribution |
| 508-11-48D | Outer Diameter 48.0 mm | In distribution |
| 621-00-36F | Alpha Code: F | In distribution |
| 542-01-50E | Outer Diameter 50.0 mm | In distribution |
| 661-10-36E | Alpha Code: E | In distribution |
| 542-01-64H | Outer Diameter 64.0 mm | In distribution |
| 623-00-32H | Lumen/Inner Diameter 32.0 mm | In distribution |
| 500-11-70I | Outer Diameter 70.0 mm | In distribution |
| 540-01-54F | Alpha Code: F | In distribution |
| 540-01-64H | Outer Diameter 64.0 mm | In distribution |
| 542-01-66I | Outer Diameter 66.0 mm | In distribution |
| 641-00-36F | Alpha Code: F | In distribution |
| 623-10-26F | Alpha Code: F | In distribution |
| 502-11-46C | Alpha Code: C | In distribution |
| 621-00-22J | Lumen/Inner Diameter 22.0 mm | In distribution |
| 542-11-44C | Alpha Code: C | In distribution |
| 621-00-22F | Lumen/Inner Diameter 22.0 mm | In distribution |
| 663-10-28H | Alpha Code: H | In distribution |
| 542-01-52E | Outer Diameter 52.0 mm | In distribution |
| 621-00-28E | Lumen/Inner Diameter 28.0 mm | In distribution |
| 641-00-32F | Alpha Code: F | In distribution |
| 663-00-36H | Alpha Code: H | In distribution |
| 542-01-60G | Alpha Code: G | In distribution |
| 621-00-28C | Alpha Code: C | In distribution |
| 623-00-26D | Alpha Code: D | In distribution |
| 641-00-28I | Lumen/Inner Diameter 28.0 mm | In distribution |
| 621-00-32E | Alpha Code: E | In distribution |
| 500-11-74J | Alpha Code: J | In distribution |
| 621-00-36E | Alpha Code: E | In distribution |
| 643-00-32F | Lumen/Inner Diameter 32.0 mm | In distribution |
| 621-00-26I | Alpha Code: I | In distribution |
| 540-01-60G | Alpha Code: G | In distribution |
| 661-10-32I | Alpha Code: I | In distribution |
| 540-11-48D | Alpha Code: D | In distribution |
| 621-10-28C | Lumen/Inner Diameter 28.0 mm | In distribution |
| 661-00-28I | Lumen/Inner Diameter 28.0 mm | In distribution |
| 661-00-28F | Lumen/Inner Diameter 28.0 mm | In distribution |
| 661-00-32H | Lumen/Inner Diameter 32.0 mm | In distribution |
| 641-00-32H | Alpha Code: H | In distribution |
| 641-00-28F | Lumen/Inner Diameter 28.0 mm | In distribution |
| 623-00-40G | Lumen/Inner Diameter 40.0 mm | In distribution |
| 621-00-26J | Alpha Code: J | In distribution |
| 661-10-32F | Lumen/Inner Diameter 32.0 mm | In distribution |
| 661-10-32H | Alpha Code: H | In distribution |
| 621-10-22J | Alpha Code: J | In distribution |
| 623-00-44J | Alpha Code: J | In distribution |
| 621-10-22G | Alpha Code: G | In distribution |
| 540-01-42B | Outer Diameter 42.0 mm | In distribution |
| 643-00-32G | Lumen/Inner Diameter 32.0 mm | In distribution |
| 661-00-32G | Lumen/Inner Diameter 32.0 mm | In distribution |
| 623-00-28A | Lumen/Inner Diameter 28.0 mm | In distribution |
| 661-00-36E | Alpha Code: E | In distribution |
| 540-01-58G | Outer Diameter 58.0 mm | In distribution |
| 641-00-28D | Alpha Code: D | In distribution |
| 502-11-48D | Alpha Code: D | In distribution |
| 641-00-36E | Lumen/Inner Diameter 36.0 mm | In distribution |
| 621-00-32D | Alpha Code: D | In distribution |
| 540-11-72J | Outer Diameter 72.0 mm | In distribution |
| 540-01-66I | Outer Diameter 66.0 mm | In distribution |
| 661-00-28D | Lumen/Inner Diameter 28.0 mm | In distribution |
| 621-10-32J | Alpha Code: J | In distribution |
| 661-10-28C | Lumen/Inner Diameter 28.0 mm | In distribution |
| 542-01-56F | Outer Diameter 56.0 mm | In distribution |
| 621-00-32H | Alpha Code: H | In distribution |
| 509-02-62G | Outer Diameter 62.0 mm | In distribution |
| 661-00-28B | Alpha Code: B | In distribution |
| 623-00-40H | Alpha Code: H | In distribution |
| 663-00-32H | Lumen/Inner Diameter 32.0 mm | In distribution |
| 661-10-32G | Alpha Code: G | In distribution |
| 641-00-36H | Alpha Code: H | In distribution |
| 502-11-76K | Outer Diameter 76.0 mm | In distribution |
| 641-00-28J | Lumen/Inner Diameter 28.0 mm | In distribution |
| 661-00-28E | Alpha Code: E | In distribution |
| 621-00-26C | Alpha Code: C | In distribution |
| 661-10-28J | Alpha Code: J | In distribution |
| 663-10-32D | Alpha Code: D | In distribution |
| 509-02-80J | Alpha Code: J | In distribution |
| 661-00-28G | Lumen/Inner Diameter 28.0 mm | In distribution |
| 643-00-36J | Alpha Code: J | In distribution |
| 621-10-36E | Lumen/Inner Diameter 36.0 mm | In distribution |
| 661-10-28G | Alpha Code: G | In distribution |
| 621-10-26I | Alpha Code: I | In distribution |
| 661-00-28J | Alpha Code: J | In distribution |
| 661-10-28H | Alpha Code: H | In distribution |
| 661-00-32J | Alpha Code: J | In distribution |
| 508-11-60G | Outer Diameter 60.0 mm | In distribution |
| 621-10-28E | Lumen/Inner Diameter 28.0 mm | In distribution |
| 661-00-32D | Lumen/Inner Diameter 32.0 mm | In distribution |
| 641-00-36G | Lumen/Inner Diameter 36.0 mm | In distribution |
| 641-00-28H | Lumen/Inner Diameter 28.0 mm | In distribution |
| 500-11-62G | Alpha Code: G | In distribution |
| 621-10-26D | Lumen/Inner Diameter 26.0 mm | In distribution |
| 661-00-32I | Alpha Code: I | In distribution |
| 509-02-76J | Alpha Code: J | In distribution |
| 661-10-28D | Lumen/Inner Diameter 28.0 mm | In distribution |
| 623-00-44H | Lumen/Inner Diameter 44.0 mm | In distribution |
| 621-00-22I | Lumen/Inner Diameter 22.0 mm | In distribution |
| 509-02-78J | Alpha Code: J | In distribution |
| 641-00-36J | Lumen/Inner Diameter 36.0 mm | In distribution |
| 540-01-44C | Outer Diameter 44.0 mm | In distribution |
| 542-01-44C | Alpha Code: C | In distribution |
| 643-00-36I | Lumen/Inner Diameter 36.0 mm | In distribution |
| 641-00-28G | Lumen/Inner Diameter 28.0 mm | In distribution |
| 663-10-36J | Lumen/Inner Diameter 36.0 mm | In distribution |
| 542-01-46D | Alpha Code: D | In distribution |
| 542-01-72J | Alpha Code: J | In distribution |
| 623-10-22A | Alpha Code: A | In distribution |
| 661-00-32E | Lumen/Inner Diameter 32.0 mm | In distribution |
| 542-01-68I | Alpha Code: I | In distribution |
| 641-00-32I | Alpha Code: I | In distribution |
| 663-10-28E | Alpha Code: E | In distribution |
| 502-01-44B | Alpha Code: B | In distribution |
| 661-10-28F | Lumen/Inner Diameter 28.0 mm | In distribution |
| 542-01-54F | Alpha Code: F | In distribution |
| 661-10-32E | Lumen/Inner Diameter 32.0 mm | In distribution |
| 500-01-50D | Alpha Code: D | In distribution |
| 661-10-32J | Lumen/Inner Diameter 32.0 mm | In distribution |
| 623-10-32I | Alpha Code: I | In distribution |
| 663-00-28C | Alpha Code: C | In distribution |
| 540-01-72J | Alpha Code: J | In distribution |
| 621-00-22A | Lumen/Inner Diameter 22.0 mm | In distribution |
| 540-01-68I | Outer Diameter 68.0 mm | In distribution |
| 542-01-62H | Alpha Code: H | In distribution |
| 509-02-60F | Outer Diameter 60.0 mm | In distribution |
| 641-00-28E | Lumen/Inner Diameter 28.0 mm | In distribution |
| 623-10-22E | Lumen/Inner Diameter 22.0 mm | In distribution |
| 661-10-28E | Alpha Code: E | In distribution |
| 621-10-28H | Alpha Code: H | In distribution |
| 641-00-28C | Lumen/Inner Diameter 28.0 mm | In distribution |
| 663-10-32H | Alpha Code: H | In distribution |
| 542-01-48D | Alpha Code: D | In distribution |
| 540-01-50E | Alpha Code: E | In distribution |
| 540-01-56F | Alpha Code: F | In distribution |
| 621-00-28H | Alpha Code: H | In distribution |
| 661-00-28H | Lumen/Inner Diameter 28.0 mm | In distribution |
| 502-11-54E | Outer Diameter 54.0 mm | In distribution |
| 623-00-40I | Lumen/Inner Diameter 40.0 mm | In distribution |
| 623-00-40E | Alpha Code: E | In distribution |
| 623-00-44I | Lumen/Inner Diameter 44.0 mm | In distribution |
| 623-10-26J | Lumen/Inner Diameter 26.0 mm | In distribution |
| 641-00-32J | Alpha Code: J | In distribution |
| 621-00-32I | Alpha Code: I | In distribution |
| 643-00-32H | Lumen/Inner Diameter 32.0 mm | In distribution |
| 540-01-52E | Outer Diameter 52.0 mm | In distribution |
| 623-10-22D | Lumen/Inner Diameter 22.0 mm | In distribution |
| 502-11-68I | Alpha Code: I | In distribution |
| 663-10-32I | Lumen/Inner Diameter 32.0 mm | In distribution |
| 621-10-36F | Lumen/Inner Diameter 36.0 mm | In distribution |
| 641-00-32E | Lumen/Inner Diameter 32.0 mm | In distribution |
| 641-00-36I | Alpha Code: I | In distribution |
| 623-00-36I | Alpha Code: I | In distribution |
| 540-01-40A | Alpha Code: A | In distribution |
| 621-10-22I | Alpha Code: I | In distribution |
| 623-00-22B | Alpha Code: B | In distribution |
| 641-00-32G | Alpha Code: G | In distribution |
| 621-10-28F | Lumen/Inner Diameter 28.0 mm | In distribution |
| 621-00-28F | Alpha Code: F | In distribution |
| 661-00-36F | Lumen/Inner Diameter 36.0 mm | In distribution |
| 661-00-28C | Lumen/Inner Diameter 28.0 mm | In distribution |
| 542-01-70J | Alpha Code: J | In distribution |
| 621-00-26G | Alpha Code: G | In distribution |
| 621-10-22H | Alpha Code: H | In distribution |
| 661-10-36F | Alpha Code: F | In distribution |
| 661-10-32D | Lumen/Inner Diameter 32.0 mm | In distribution |
| 500-01-74J | Outer Diameter 74.0 mm | In distribution |
| 621-10-32D | Alpha Code: D | In distribution |
| 621-10-32G | Alpha Code: G | In distribution |
| 542-01-40A | Outer Diameter 40.0 mm | In distribution |
| 540-01-70J | Outer Diameter 70.0 mm | In distribution |
| 623-10-32E | Lumen/Inner Diameter 32.0 mm | In distribution |
| 643-00-28F | Lumen/Inner Diameter 28.0 mm | In distribution |
| 661-10-28I | Lumen/Inner Diameter 28.0 mm | In distribution |
| 621-10-26C | Lumen/Inner Diameter 26.0 mm | In distribution |
| 502-11-56F | Alpha Code: F | In distribution |
| 502-01-52E | Outer Diameter 52.0 mm | In distribution |
| 540-01-62H | Alpha Code: H | In distribution |
| 621-00-26H | Alpha Code: H | In distribution |
| 540-01-48D | Alpha Code: D | In distribution |
| 540-01-46D | Outer Diameter 46.0 mm | In distribution |
| 663-00-28E | Alpha Code: E | In distribution |
| 502-01-42A | Outer Diameter 42.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121308 | 2012-07-30 |
| K101072 | 2011-04-11 |
| K102019 | 2011-03-03 |
| K090897 | 2009-10-23 |
| K081171 | 2008-07-22 |
| K062419 | 2006-11-15 |
| K061434 | 2006-08-22 |
| K061168 | 2006-07-18 |
| K033716 | 2005-02-10 |
| K032581 | 2003-10-09 |
| K021911 | 2002-07-02 |
| K020497 | 2002-03-04 |
| K013475 | 2001-12-20 |
| K010170 | 2001-04-18 |
| K990849 | 1999-12-20 |
| K993352 | 1999-11-19 |
Recalls Naming This Product
7 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 |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US | |
| Howmedica Osteonics Corp | 510(k) number | 2015-06-25 | Class II | Nonconforming Material/Component | it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field. | 16 units | 2017-08-30 |
| Howmedica Osteonics Corp | 510(k) number | 2014-12-15 | Class II | Process control | Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present. | seven units | 2016-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-08-30 | Not classified | Process control | Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one s | 142 units | 2008-09-05 |
| Howmedica Osteonics Corp | 510(k) number | 2007-08-30 | Not classified | Process control | Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one s | 142 units | 2008-09-05 |
| Howmedica Osteonics Corp | 510(k) number | 2006-03-13 | Not classified | Other | Dimensional anomaly | 1,220 units | 2008-01-18 |
| Howmedica Osteonics Corp | 510(k) number | 2006-02-17 | Not classified | Process design | Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts. | 594 units total – all products. | 2010-03-03 |
Recalls
34 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 |
|---|---|---|---|---|---|
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 3 units | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 45 units | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 48 units | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 225 units | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2021-12-21 | Class II | Under Investigation by firm | There is a potential for the outer Tyvek lid to de-bond from the sealed package. | 8 units | |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 2021-11-15 | |
| 2019-10-03 | Class II | Employee error | Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015) | 40 units | 2022-04-21 |
| 2017-07-21 | Class II | Process control | Inner and outer sterile barriers not fully sealed. | 255 | 2020-03-12 |
| 2017-07-21 | Class II | Process control | Inner and outer sterile barriers not fully sealed. | 255 | 2020-03-12 |
| 2016-06-03 | Class II | Process design | Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. | 1,864 units | 2018-08-01 |
| 2015-09-08 | Class II | Process design | Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. | 201 | 2017-07-25 |
| 2014-08-15 | Class II | Under Investigation by firm | The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier. | 1,147 in total | 2018-01-05 |
| 2007-09-28 | Not classified | Packaging process control | Mis-labeling: The warning label “Do not use with heads more than +10mm offset” does not appear on 127 degree stem boxes. | 30 | 2008-10-27 |
| 2007-09-28 | Not classified | Packaging process control | Mis-labeling: The warning label “Do not use with heads more than +10mm offset” does not appear on 127 degree stem boxes. | 46 | 2008-10-27 |
| 2007-09-28 | Not classified | Other | Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted. | 192 protocols | 2008-09-05 |
| 2007-09-28 | Not classified | Packaging process control | Mis-labeling: The warning label “Do not use with heads more than +10mm offset” does not appear on 127 degree stem boxes. | 44 | 2008-10-27 |
| 2007-09-28 | Not classified | Packaging process control | Mis-labeled: The warning label “Do not use with heads more than +10mm offset” does not appear on 127 degree stem boxes. | 59 | 2008-10-27 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
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.