|
Device |
orthopedic manual surgical instrument |
Product Code | LXH |
Regulation Number |
888.4540
|
Device Class |
1
|
MDR Year |
MDR Reports |
MDR Events |
2019 |
5224 |
5233 |
2020 |
4767 |
4772 |
2021 |
4833 |
4884 |
2022 |
4845 |
4913 |
2023 |
5182 |
5195 |
2024 |
5872 |
5872 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Acumed LLC |
II |
Dec-26-2023 |
2 |
Aesculap Implant Systems LLC |
II |
Jul-21-2022 |
3 |
Aesculap Implant Systems LLC |
II |
Jul-21-2022 |
4 |
Aesculap Implant Systems LLC |
II |
Jul-15-2022 |
5 |
Arthrex, Inc. |
II |
May-05-2022 |
6 |
Arthrex, Inc. |
II |
Jan-30-2020 |
7 |
Biomet |
II |
Jun-12-2020 |
8 |
ConMed Corporation |
II |
Apr-27-2021 |
9 |
ConMed Corporation |
II |
Dec-21-2020 |
10 |
DePuy Orthopaedics, Inc. |
II |
Apr-11-2019 |
11 |
Encore Medical, Lp |
II |
Dec-06-2019 |
12 |
Gauthier Biomedical, Inc. |
II |
Nov-27-2024 |
13 |
Howmedica Osteonics Corp. |
II |
Jun-18-2024 |
14 |
Howmedica Osteonics Corp. |
II |
Feb-06-2024 |
15 |
Howmedica Osteonics Corp. |
II |
Jun-14-2023 |
16 |
In2bones USA, LLC |
II |
Sep-22-2021 |
17 |
Intrinsic Therapeutics, Inc. |
II |
Aug-20-2024 |
18 |
K2M, Inc |
II |
Dec-07-2020 |
19 |
Laboratoires Bodycad, Inc. |
II |
Nov-17-2021 |
20 |
Medacta Usa Inc |
II |
Jun-07-2022 |
21 |
Medtronic Sofamor Danek USA Inc |
II |
May-10-2023 |
22 |
Mizuho OSI |
II |
Aug-24-2022 |
23 |
OMNIlife science Inc. |
II |
Feb-14-2019 |
24 |
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL |
II |
Aug-29-2024 |
25 |
Pega Medical Inc. |
III |
May-15-2020 |
26 |
Pega Medical Inc. |
II |
Nov-01-2019 |
27 |
SONEX HEALTH LLC |
II |
Jul-15-2022 |
28 |
Smith & Nephew, Inc. |
II |
Aug-10-2020 |
29 |
Smith & Nephew, Inc. |
II |
Nov-08-2019 |
30 |
Smith & Nephew, Inc. |
II |
Jan-12-2019 |
31 |
Spineology, Inc. |
II |
Oct-17-2024 |
32 |
Stryker Spine |
II |
Dec-21-2023 |
33 |
Synthes (USA) Products LLC |
II |
Feb-10-2022 |
34 |
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
II |
Jul-03-2023 |
35 |
TeDan Surgical Innovations LLC |
II |
Jul-10-2020 |
36 |
TeDan Surgical Innovations LLC |
II |
Mar-17-2020 |
37 |
Tornier, Inc |
II |
Jun-01-2022 |
38 |
TriMed Inc. |
II |
Nov-12-2019 |
39 |
Waldemar Link GmbH & Co. KG (Corp. Hq.) |
II |
Sep-24-2024 |
40 |
Waldemar Link GmbH & Co. KG (Mfg Site) |
II |
Aug-29-2023 |
41 |
Zimmer Biomet, Inc. |
II |
Jun-02-2020 |
42 |
Zimmer Biomet, Inc. |
II |
Jan-28-2020 |
43 |
Zimmer Biomet, Inc. |
II |
Dec-03-2019 |
44 |
Zimmer Biomet, Inc. |
II |
Nov-22-2019 |
45 |
Zimmer Biomet, Inc. |
II |
Nov-07-2019 |
46 |
Zimmer Biomet, Inc. |
II |
Jul-04-2019 |
47 |
Zimmer Biomet, Inc. |
II |
Jun-19-2019 |
48 |
Zimmer Biomet, Inc. |
II |
Jun-06-2019 |
49 |
restor3d Inc. |
II |
Apr-29-2022 |
|
|
|
|