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RingLoc® Hip System
Model XL-108223 · Biomet Orthopedics, LLC · DI 00880304651494
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
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
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 (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2016-12-19
Z-1024-2017
Class II
Terminated
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
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
3.31
2019-02
0
2.8
2019-03
0
3.16
2019-04
0
2.96
2019-05
0
2.28
2019-06
0
1.97
2019-07
0
1.98
2019-08
0
2.28
2019-09
0
2.6
2019-10
0
2.82
2019-11
0
2.33
2019-12
0
2.68
2020-01
0
3.13
2020-02
0
2.75
2020-03
0
3.52
2020-04
0
2.44
2020-05
0
2.42
2020-06
0
2.22
2020-07
0
2.73
2020-08
0
2.19
2020-09
0
2.78
2020-10
0
2.78
2020-11
0
2.5
2020-12
0
2.5
2021-01
0
2.63
2021-02
0
2.22
2021-03
0
2.21
2021-04
0
2.21
2021-05
0
2.15
2021-06
0
2.68
2021-07
0
2.52
2021-08
0
2.47
2021-09
0
2.58
2021-10
0
2.35
2021-11
0
2.26
2021-12
0
2.53
2022-01
0
2.25
2022-02
0
2.27
2022-03
0
2.36
2022-04
0
2.33
2022-05
0
2.28
2022-06
0
2.41
2022-07
0
2.25
2022-08
0
2.33
2022-09
0
2.33
2022-10
0
2.31
2022-11
0
2.41
2022-12
0
2.42
2023-01
0
2.41
2023-02
0
2.3
2023-03
0
2.54
2023-04
0
2.41
2023-05
0
2.36
2023-06
0
2.43
2023-07
0
2.25
2023-08
0
2.09
2023-09
0
2.08
2023-10
0
1.77
2023-11
0
1.73
2023-12
0
1.83
2024-01
0
1.82
2024-02
0
2.17
2024-03
0
2.04
2024-04
0
1.85
2024-05
0
2.19
2024-06
0
2
2024-07
0
1.81
2024-08
0
1.96
2024-09
0
2.13
2024-10
0
1.86
2024-11
0
1.87
2024-12
0
1.64
2025-01
0
2.04
2025-02
0
1.59
2025-03
0
1.81
2025-04
0
1.88
2025-05
0
1.8
2025-06
0
1.9
2025-07
0
1.88
2025-08
0
1.8
2025-09
0
1.81
2025-10
0
1.78
2025-11
0
1.88
2025-12
0
1.96
2026-01
0
2.05
2026-02
0
1.72
2026-03
0
2.04
2026-04
0
1.97
2026-05
0
1.83
2026-06
0
1.82
This device (reports/month)Average device in JDI, LPH, LZO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K042051 — cited as predicate by K110555, K160895, K181491
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC