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RingLoc Hip System
Model EP-108627 · Biomet Orthopedics, LLC · DI 00880304484931
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360
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
OGH — Laryngoscope Kit · Class I · 21 CFR 868.5540
OGI — Nasal Endotracheal Tube Holder Kit · Class I · 21 CFR 868.5770
OIY — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive · Class II · 21 CFR 888.3560
OQG — Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented · Class II · 21 CFR 888.3358
UDILibrary device dossier · generated 2026-09-13 · 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 (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
2.86
2019-02
0
2.47
2019-03
0
2.57
2019-04
0
2.56
2019-05
0
2.11
2019-06
0
1.97
2019-07
0
1.97
2019-08
0
2.27
2019-09
0
2.32
2019-10
0
2.66
2019-11
0
2.63
2019-12
0
2.54
2020-01
0
2.74
2020-02
0
2.63
2020-03
0
2.9
2020-04
0
2.22
2020-05
0
2.08
2020-06
0
2.06
2020-07
0
2.55
2020-08
0
2.2
2020-09
0
2.4
2020-10
0
2.65
2020-11
0
2.51
2020-12
0
2.56
2021-01
0
2.41
2021-02
0
2.18
2021-03
0
2.24
2021-04
0
2.18
2021-05
0
2.12
2021-06
0
2.38
2021-07
0
2.31
2021-08
0
2.17
2021-09
0
2.37
2021-10
0
2.11
2021-11
0
2.14
2021-12
0
2.33
2022-01
0
2.04
2022-02
0
2.16
2022-03
0
2.12
2022-04
0
2.13
2022-05
0
2.17
2022-06
0
2.15
2022-07
0
2.09
2022-08
0
2.14
2022-09
0
2.2
2022-10
0
2.13
2022-11
0
2.23
2022-12
0
2.06
2023-01
0
2.17
2023-02
0
2.14
2023-03
0
2.26
2023-04
0
2.24
2023-05
0
2.24
2023-06
0
2.22
2023-07
0
2.07
2023-08
0
1.91
2023-09
0
1.88
2023-10
0
1.64
2023-11
0
1.64
2023-12
0
1.72
2024-01
0
1.69
2024-02
0
1.92
2024-03
0
1.89
2024-04
0
1.71
2024-05
0
2
2024-06
0
1.93
2024-07
0
1.76
2024-08
0
2.03
2024-09
0
1.99
2024-10
0
1.84
2024-11
0
1.81
2024-12
0
1.71
2025-01
0
2.01
2025-02
0
1.61
2025-03
0
1.75
2025-04
0
1.75
2025-05
0
1.69
2025-06
0
1.79
2025-07
0
1.73
2025-08
0
1.67
2025-09
0
1.69
2025-10
0
1.63
2025-11
0
1.74
2025-12
0
1.8
2026-01
0
1.81
2026-02
0
1.58
2026-03
0
1.91
2026-04
0
1.79
2026-05
0
1.69
2026-06
0
1.7
This device (reports/month)Average device in JDI, JWH, LPH, LWJ, LZO, MAY, OGH, OGI, OIY, OQG (reports/device/month)