Print-ready dossier — use your browser's print dialog to save as PDF.
LFIT
Model 6260-9-236 · Howmedica Osteonics Corp. · DI 07613327032314
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390
LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (211)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Injury: 211
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
7
2.58
2019-02
4
2.2
2019-03
8
2.34
2019-04
6
2.33
2019-05
2
1.91
2019-06
6
1.65
2019-07
4
1.73
2019-08
6
1.9
2019-09
7
1.97
2019-10
3
2.11
2019-11
3
1.69
2019-12
2
1.96
2020-01
3
2.17
2020-02
1
2.16
2020-03
1
2.7
2020-04
5
1.87
2020-05
1
1.97
2020-06
3
1.7
2020-07
3
2.13
2020-08
3
1.63
2020-09
1
1.84
2020-10
4
1.97
2020-11
4
1.88
2020-12
0
1.94
2021-01
0
1.98
2021-02
1
1.7
2021-03
2
1.76
2021-04
4
1.66
2021-05
2
1.64
2021-06
4
2.05
2021-07
3
1.88
2021-08
2
1.77
2021-09
2
1.9
2021-10
3
1.8
2021-11
5
1.76
2021-12
4
1.95
2022-01
2
1.64
2022-02
1
1.94
2022-03
0
1.68
2022-04
1
1.85
2022-05
1
1.75
2022-06
2
1.8
2022-07
3
1.77
2022-08
2
1.9
2022-09
2
1.84
2022-10
2
1.78
2022-11
0
1.88
2022-12
2
1.73
2023-01
1
1.93
2023-02
3
1.75
2023-03
0
1.8
2023-04
1
1.86
2023-05
4
1.89
2023-06
4
1.94
2023-07
1
1.96
2023-08
1
1.91
2023-09
1
1.94
2023-10
4
1.48
2023-11
1
1.48
2023-12
0
1.51
2024-01
2
1.61
2024-02
0
1.74
2024-03
6
1.95
2024-04
3
1.62
2024-05
1
2.09
2024-06
4
1.85
2024-07
2
1.61
2024-08
1
1.84
2024-09
0
1.93
2024-10
0
1.6
2024-11
4
1.44
2024-12
2
1.46
2025-01
9
1.52
2025-02
2
1.38
2025-03
2
1.67
2025-04
1
1.69
2025-05
0
1.39
2025-06
0
1.63
2025-07
2
1.65
2025-08
1
1.44
2025-09
2
1.63
2025-10
1
1.64
2025-11
3
1.7
2025-12
1
1.69
2026-01
0
1.84
2026-02
2
1.46
2026-03
1
1.91
2026-04
1
1.65
2026-05
0
1.59
2026-06
0
1.56
This device (reports/month)Average device in JDI, KWY, LWJ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Howmedica Osteonics Corp.
VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
NAI 2021-06-22 Howmedica Osteonics Corp. · 0 citations
VAI 2015-03-09 Howmedica Osteonics Corp. · 3 citations
VAI 2013-04-16 Howmedica Osteonics Corp. · 3 citations
NAI 2010-01-15 Howmedica Osteonics Corp. · 0 citations