|
Device |
prosthesis, hip, semi-constrained, metal/polymer, cemented |
Product Code | JDI |
Regulation Number |
888.3350
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BIOMET MANUFACTURING LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BIOPRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORIN USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORIN USA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY IRELAND UC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXCERA ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MATERIALISE N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAXX ORTHOPEDICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROPORT ORTHOPEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ONKOS SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STANMORE IMPLANTS WORLDWIDE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGTECH, INC., |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED ORTHOPEDIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Biomet, Inc. |
II |
Jun-25-2024 |
2 |
Biomet, Inc. |
II |
Dec-17-2020 |
3 |
Biomet, Inc. |
II |
Oct-09-2020 |
4 |
Biomet, Inc. |
II |
May-28-2020 |
5 |
Biomet, Inc. |
III |
Jun-11-2015 |
6 |
Biomet, Inc. |
II |
Dec-17-2014 |
7 |
Biopro, Inc. |
II |
Nov-04-2011 |
8 |
Corin Ltd |
II |
Aug-31-2022 |
9 |
Corin Ltd |
II |
Aug-09-2022 |
10 |
DePuy Orthopaedics, Inc. |
II |
Jun-10-2021 |
11 |
DePuy Orthopaedics, Inc. |
II |
Jun-29-2012 |
12 |
Encore Medical, Lp |
II |
Jan-11-2012 |
13 |
Exactech, Inc. |
II |
Sep-09-2022 |
14 |
Exactech, Inc. |
II |
Jan-17-2017 |
15 |
Howmedica Osteonics Corp. |
II |
Aug-26-2024 |
16 |
Howmedica Osteonics Corp. |
II |
Jan-15-2020 |
17 |
Howmedica Osteonics Corp. |
II |
Oct-11-2018 |
18 |
Medacta Usa Inc |
II |
Nov-08-2012 |
19 |
MicroPort Orthopedics Inc. |
II |
Jun-02-2022 |
20 |
Smith & Nephew Inc |
II |
Nov-20-2009 |
21 |
Smith & Nephew, Inc. |
II |
May-09-2018 |
22 |
Smith & Nephew, Inc. |
II |
Jan-11-2017 |
23 |
Stryker Howmedica Osteonics Corp. |
II |
Nov-09-2016 |
24 |
Stryker Howmedica Osteonics Corp. |
II |
Aug-11-2016 |
25 |
Stryker Howmedica Osteonics Corp. |
II |
Nov-17-2015 |
26 |
Stryker Howmedica Osteonics Corp. |
II |
Mar-03-2015 |
27 |
Stryker Howmedica Osteonics Corp. |
II |
Dec-07-2013 |
28 |
Stryker Howmedica Osteonics Corp. |
II |
Nov-13-2012 |
29 |
Stryker Howmedica Osteonics Corp. |
II |
Jul-10-2012 |
30 |
Stryker Howmedica Osteonics Corp. |
II |
May-13-2010 |
31 |
Stryker Howmedica Osteonics Corp. |
II |
May-12-2010 |
32 |
Stryker Howmedica Osteonics Corp. |
II |
Jan-26-2009 |
33 |
Zimmer Biomet, Inc. |
II |
Nov-02-2020 |
34 |
Zimmer Biomet, Inc. |
II |
Aug-09-2019 |
35 |
Zimmer Biomet, Inc. |
II |
Dec-04-2018 |
36 |
Zimmer Biomet, Inc. |
II |
Aug-14-2018 |
37 |
Zimmer Biomet, Inc. |
II |
Apr-27-2018 |
38 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
39 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
40 |
Zimmer Biomet, Inc. |
II |
Dec-29-2017 |
41 |
Zimmer Biomet, Inc. |
II |
Mar-27-2017 |
42 |
Zimmer Biomet, Inc. |
II |
Feb-22-2016 |
43 |
Zimmer Inc. |
II |
Jan-25-2012 |
44 |
Zimmer Inc. |
II |
Sep-27-2011 |
45 |
Zimmer Inc. |
II |
Jul-23-2009 |
46 |
Zimmer Manufacturing B.V. |
II |
May-16-2016 |
47 |
Zimmer Manufacturing B.V. |
II |
Mar-12-2016 |
48 |
Zimmer Trabecular Metal Technology, Inc. |
II |
Jun-10-2016 |
49 |
Zimmer, Inc. |
II |
Jul-30-2024 |
50 |
Zimmer, Inc. |
II |
Sep-07-2023 |
51 |
Zimmer, Inc. |
II |
Oct-20-2014 |
52 |
Zimmer, Inc. |
II |
Aug-26-2014 |
53 |
Zimmer, Inc. |
II |
Feb-20-2014 |
54 |
Zimmer, Inc. |
II |
Dec-30-2013 |
55 |
Zimmer, Inc. |
II |
Nov-14-2013 |
56 |
Zimmer, Inc. |
II |
Oct-25-2013 |
57 |
Zimmer, Inc. |
II |
Nov-06-2012 |
58 |
Zimmer, Inc. |
II |
Oct-15-2012 |
|
|
|
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