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CORAIL

Model L20106 · DEPUY (IRELAND) · DI 10603295257998

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

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 (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (1)

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: 1

11232019-01: 0 reports for this device; peer average 2.28/device2019-02: 0 reports for this device; peer average 2.1/device2019-03: 0 reports for this device; peer average 2.3/device2019-04: 0 reports for this device; peer average 2.27/device2019-05: 0 reports for this device; peer average 1.86/device2019-06: 0 reports for this device; peer average 1.64/device2019-07: 0 reports for this device; peer average 1.59/device2019-08: 0 reports for this device; peer average 1.99/device2019-09: 0 reports for this device; peer average 1.88/device2019-10: 0 reports for this device; peer average 2.13/device2019-11: 0 reports for this device; peer average 1.93/device2019-12: 0 reports for this device; peer average 2.12/device2020-01: 0 reports for this device; peer average 2.43/device2020-02: 0 reports for this device; peer average 2.18/device2020-03: 0 reports for this device; peer average 2.68/device2020-04: 0 reports for this device; peer average 2.03/device2020-05: 0 reports for this device; peer average 1.89/device2020-06: 0 reports for this device; peer average 1.83/device2020-07: 0 reports for this device; peer average 2.3/device2020-08: 0 reports for this device; peer average 1.88/device2020-09: 0 reports for this device; peer average 2.28/device2020-10: 1 reports for this device; peer average 2.25/device2020-11: 0 reports for this device; peer average 2.03/device2020-12: 0 reports for this device; peer average 2.11/device2021-01: 0 reports for this device; peer average 2.14/device2021-02: 0 reports for this device; peer average 1.88/device2021-03: 0 reports for this device; peer average 1.89/device2021-04: 0 reports for this device; peer average 1.89/device2021-05: 0 reports for this device; peer average 1.86/device2021-06: 0 reports for this device; peer average 2.19/device2021-07: 0 reports for this device; peer average 2.19/device2021-08: 0 reports for this device; peer average 2.14/device2021-09: 0 reports for this device; peer average 2.36/device2021-10: 0 reports for this device; peer average 2.12/device2021-11: 0 reports for this device; peer average 1.9/device2021-12: 0 reports for this device; peer average 2.05/device2022-01: 0 reports for this device; peer average 1.93/device2022-02: 0 reports for this device; peer average 1.98/device2022-03: 0 reports for this device; peer average 2.01/device2022-04: 0 reports for this device; peer average 1.98/device2022-05: 0 reports for this device; peer average 2.12/device2022-06: 0 reports for this device; peer average 2.02/device2022-07: 0 reports for this device; peer average 2.02/device2022-08: 0 reports for this device; peer average 2.1/device2022-09: 0 reports for this device; peer average 2.17/device2022-10: 0 reports for this device; peer average 2.08/device2022-11: 0 reports for this device; peer average 2.17/device2022-12: 0 reports for this device; peer average 1.98/device2023-01: 0 reports for this device; peer average 2.26/device2023-02: 0 reports for this device; peer average 2.03/device2023-03: 0 reports for this device; peer average 2.13/device2023-04: 0 reports for this device; peer average 2.24/device2023-05: 0 reports for this device; peer average 2.1/device2023-06: 0 reports for this device; peer average 2.26/device2023-07: 0 reports for this device; peer average 2.21/device2023-08: 0 reports for this device; peer average 1.99/device2023-09: 0 reports for this device; peer average 2.03/device2023-10: 0 reports for this device; peer average 1.68/device2023-11: 0 reports for this device; peer average 1.66/device2023-12: 0 reports for this device; peer average 1.74/device2024-01: 0 reports for this device; peer average 1.75/device2024-02: 0 reports for this device; peer average 2.04/device2024-03: 0 reports for this device; peer average 2.05/device2024-04: 0 reports for this device; peer average 1.86/device2024-05: 0 reports for this device; peer average 2.35/device2024-06: 0 reports for this device; peer average 2.06/device2024-07: 0 reports for this device; peer average 1.75/device2024-08: 0 reports for this device; peer average 2.12/device2024-09: 0 reports for this device; peer average 2.07/device2024-10: 0 reports for this device; peer average 1.83/device2024-11: 0 reports for this device; peer average 1.76/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 1.93/device2025-02: 0 reports for this device; peer average 1.57/device2025-03: 0 reports for this device; peer average 1.78/device2025-04: 0 reports for this device; peer average 1.83/device2025-05: 0 reports for this device; peer average 1.73/device2025-06: 0 reports for this device; peer average 1.84/device2025-07: 0 reports for this device; peer average 1.8/device2025-08: 0 reports for this device; peer average 1.75/device2025-09: 0 reports for this device; peer average 1.66/device2025-10: 0 reports for this device; peer average 1.71/device2025-11: 0 reports for this device; peer average 1.76/device2025-12: 0 reports for this device; peer average 1.87/device2026-01: 0 reports for this device; peer average 1.89/device2026-02: 0 reports for this device; peer average 1.7/device2026-03: 0 reports for this device; peer average 1.94/device2026-04: 0 reports for this device; peer average 1.88/device2026-05: 0 reports for this device; peer average 1.74/device2026-06: 0 reports for this device; peer average 1.79/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.28
2019-0202.1
2019-0302.3
2019-0402.27
2019-0501.86
2019-0601.64
2019-0701.59
2019-0801.99
2019-0901.88
2019-1002.13
2019-1101.93
2019-1202.12
2020-0102.43
2020-0202.18
2020-0302.68
2020-0402.03
2020-0501.89
2020-0601.83
2020-0702.3
2020-0801.88
2020-0902.28
2020-1012.25
2020-1102.03
2020-1202.11
2021-0102.14
2021-0201.88
2021-0301.89
2021-0401.89
2021-0501.86
2021-0602.19
2021-0702.19
2021-0802.14
2021-0902.36
2021-1002.12
2021-1101.9
2021-1202.05
2022-0101.93
2022-0201.98
2022-0302.01
2022-0401.98
2022-0502.12
2022-0602.02
2022-0702.02
2022-0802.1
2022-0902.17
2022-1002.08
2022-1102.17
2022-1201.98
2023-0102.26
2023-0202.03
2023-0302.13
2023-0402.24
2023-0502.1
2023-0602.26
2023-0702.21
2023-0801.99
2023-0902.03
2023-1001.68
2023-1101.66
2023-1201.74
2024-0101.75
2024-0202.04
2024-0302.05
2024-0401.86
2024-0502.35
2024-0602.06
2024-0701.75
2024-0802.12
2024-0902.07
2024-1001.83
2024-1101.76
2024-1201.63
2025-0101.93
2025-0201.57
2025-0301.78
2025-0401.83
2025-0501.73
2025-0601.84
2025-0701.8
2025-0801.75
2025-0901.66
2025-1001.71
2025-1101.76
2025-1201.87
2026-0101.89
2026-0201.7
2026-0301.94
2026-0401.88
2026-0501.74
2026-0601.79
This device (reports/month)Average device in LWJ, LZO, MEH (reports/device/month)

Regulatory clearances

  • K192946 SESE 2019-11-26 (k number procode)

Predicate lineage

K042992 — cited as predicate by K093736, K112091, K112150, K123392, K123991, K153381, K161155, K161840, K162719, K171249, K172857, K180973, K182048, K183312, K190904, K192946, K203167, K211657, K213839, K223745, K240528

K070554 — cited as predicate by K123991, K161840, K171249, K192946, K203167, K240528

K192946 — cites (transitively): K042992 (d1), K070554 (d1), K093736 (d1), K123991 (d1), K173960 (d1), K961732 (d2), K812672 (d2), K903084 (d2) — cited as predicate by K203167, K211657, K213839, K231873

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — DEPUY (IRELAND)

  • NAI 2024-07-04 DEPUY (IRELAND) · 0 citations
  • NAI 2015-01-08 DEPUY (IRELAND) · 0 citations
  • VAI 2012-01-26 DEPUY (IRELAND) · 1 citations
  • NAI 2011-02-03 DEPUY (IRELAND) · 0 citations