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Model 1236-2-848 · Howmedica Osteonics Corp. · DI 04546540638977
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
UDILibrary device dossier · generated 2026-09-06 · 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 (80)
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: 80
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
1
2.38
2019-02
2
2.17
2019-03
1
2.44
2019-04
1
2.41
2019-05
0
1.91
2019-06
1
1.68
2019-07
1
1.62
2019-08
2
2
2019-09
4
1.95
2019-10
1
2.18
2019-11
1
2.02
2019-12
2
2.22
2020-01
0
2.6
2020-02
2
2.2
2020-03
3
2.76
2020-04
1
2.1
2020-05
2
1.96
2020-06
4
1.9
2020-07
0
2.35
2020-08
1
1.97
2020-09
3
2.43
2020-10
3
2.38
2020-11
3
2.11
2020-12
3
2.16
2021-01
2
2.24
2021-02
2
1.96
2021-03
3
1.94
2021-04
0
1.96
2021-05
0
1.97
2021-06
1
2.23
2021-07
1
2.25
2021-08
2
2.21
2021-09
0
2.45
2021-10
2
2.19
2021-11
1
1.98
2021-12
0
2.12
2022-01
1
2.01
2022-02
0
2.06
2022-03
2
2.07
2022-04
2
2.05
2022-05
0
2.19
2022-06
1
2.09
2022-07
1
2.05
2022-08
1
2.11
2022-09
1
2.2
2022-10
1
2.13
2022-11
1
2.22
2022-12
0
2.07
2023-01
0
2.26
2023-02
0
2.08
2023-03
0
2.19
2023-04
0
2.24
2023-05
2
2.13
2023-06
0
2.26
2023-07
0
2.16
2023-08
2
1.92
2023-09
0
1.97
2023-10
0
1.67
2023-11
0
1.64
2023-12
0
1.74
2024-01
0
1.72
2024-02
0
2.06
2024-03
1
1.97
2024-04
1
1.82
2024-05
0
2.22
2024-06
0
1.97
2024-07
1
1.71
2024-08
2
2.03
2024-09
0
1.97
2024-10
0
1.81
2024-11
0
1.79
2024-12
0
1.62
2025-01
0
1.99
2025-02
2
1.58
2025-03
0
1.8
2025-04
1
1.84
2025-05
0
1.78
2025-06
0
1.87
2025-07
0
1.81
2025-08
0
1.78
2025-09
0
1.67
2025-10
0
1.72
2025-11
0
1.8
2025-12
0
1.92
2026-01
1
1.92
2026-02
0
1.72
2026-03
0
1.95
2026-04
0
1.97
2026-05
0
1.76
2026-06
0
1.8
This device (reports/month)Average device in LZO, MEH (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