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Arcos Modular Revision Hip System
Model 11-301325 · Biomet Orthopedics, LLC · DI 00880304480575
JDC — Prosthesis, Elbow, Constrained, Cemented · Class II · 21 CFR 888.3150
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
KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer · Class II · 21 CFR 888.3310
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
MAY — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish · 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 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2021-06-02
Z-2269-2021
Class II
Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion
and device failure in vivo leading to surgical intervention
code info di
Adverse-event reports — MAUDE (0)
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.8
2019-02
0
2.41
2019-03
0
2.73
2019-04
0
2.6
2019-05
0
2.07
2019-06
0
1.75
2019-07
0
1.78
2019-08
0
2.03
2019-09
0
2.23
2019-10
0
2.41
2019-11
0
2.04
2019-12
0
2.32
2020-01
0
2.65
2020-02
0
2.37
2020-03
0
3
2020-04
0
2.13
2020-05
0
2.1
2020-06
0
1.95
2020-07
0
2.39
2020-08
0
1.91
2020-09
0
2.38
2020-10
0
2.37
2020-11
0
2.18
2020-12
0
2.21
2021-01
0
2.35
2021-02
0
1.95
2021-03
0
1.94
2021-04
0
1.95
2021-05
0
1.92
2021-06
0
2.35
2021-07
0
2.19
2021-08
0
2.14
2021-09
0
2.28
2021-10
0
2.11
2021-11
0
1.97
2021-12
0
2.18
2022-01
0
1.96
2022-02
0
1.98
2022-03
0
2.04
2022-04
0
2.05
2022-05
0
2.04
2022-06
0
2.11
2022-07
0
1.98
2022-08
0
2.05
2022-09
0
2.08
2022-10
0
2.03
2022-11
0
2.12
2022-12
0
2.05
2023-01
0
2.15
2023-02
0
2.01
2023-03
0
2.2
2023-04
0
2.13
2023-05
0
2.07
2023-06
0
2.12
2023-07
0
2.02
2023-08
0
1.89
2023-09
0
1.89
2023-10
0
1.6
2023-11
0
1.56
2023-12
0
1.65
2024-01
0
1.69
2024-02
0
1.97
2024-03
0
1.89
2024-04
0
1.69
2024-05
0
1.98
2024-06
0
1.84
2024-07
0
1.67
2024-08
0
1.83
2024-09
0
1.98
2024-10
0
1.72
2024-11
0
1.67
2024-12
0
1.52
2025-01
0
1.83
2025-02
0
1.49
2025-03
0
1.77
2025-04
0
1.77
2025-05
0
1.65
2025-06
0
1.78
2025-07
0
1.78
2025-08
0
1.64
2025-09
0
1.67
2025-10
0
1.69
2025-11
0
1.75
2025-12
0
1.84
2026-01
0
1.91
2026-02
0
1.58
2026-03
0
1.87
2026-04
0
1.83
2026-05
0
1.63
2026-06
0
1.69
This device (reports/month)Average device in JDC, JDI, KWY, KWZ, LPH, LZO, MAY, MEH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Biomet Orthopedics, LLC