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GLOBAL UNITE

Model 1100-16-100 · DEPUY (IRELAND) · DI 10603295004189

HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660

MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3670

PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660

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 (8)

Initiated	Recall #	Class	Status	Reason	Link basis
2021-12-07	Z-0483-2022	Class II	Terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage	k number procode
2021-12-07	Z-0484-2022	Class II	Terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage	k number procode
2021-12-07	Z-0485-2022	Class II	Terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage	k number procode
2021-12-07	Z-0486-2022	Class II	Terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage	k number procode
2021-12-07	Z-0487-2022	Class II	Terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage	k number procode
2021-12-07	Z-0488-2022	Class II	Terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage	k number procode
2021-12-07	Z-0489-2022	Class II	Terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage	k number procode
2021-12-07	Z-0490-2022	Class II	Terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage	code info di

Adverse-event reports — MAUDE (4)

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: 4

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	1.79
2019-02	0	1.72
2019-03	0	1.71
2019-04	0	1.79
2019-05	0	2
2019-06	1	1.84
2019-07	0	1.57
2019-08	0	2.11
2019-09	0	1.64
2019-10	0	1.81
2019-11	0	1.67
2019-12	0	1.74
2020-01	0	1.96
2020-02	0	2.08
2020-03	0	1.97
2020-04	0	1.72
2020-05	0	1.63
2020-06	0	1.91
2020-07	0	2.15
2020-08	0	1.79
2020-09	0	1.97
2020-10	0	2.1
2020-11	0	1.85
2020-12	0	1.81
2021-01	0	2.05
2021-02	0	2
2021-03	0	2.09
2021-04	1	2
2021-05	0	1.93
2021-06	0	1.78
2021-07	0	2.01
2021-08	0	2.21
2021-09	0	1.9
2021-10	0	2.13
2021-11	0	2.08
2021-12	0	2.32
2022-01	0	2.52
2022-02	0	2.31
2022-03	0	2.33
2022-04	0	2.34
2022-05	0	2.07
2022-06	0	2.18
2022-07	0	2.19
2022-08	0	2.17
2022-09	0	1.96
2022-10	0	1.98
2022-11	0	2.05
2022-12	0	1.95
2023-01	0	1.81
2023-02	0	1.93
2023-03	0	2.01
2023-04	0	2.16
2023-05	0	2.06
2023-06	0	2.23
2023-07	0	2.02
2023-08	0	1.67
2023-09	0	1.5
2023-10	0	1.6
2023-11	0	1.63
2023-12	0	1.41
2024-01	0	1.76
2024-02	0	1.78
2024-03	0	1.63
2024-04	1	1.81
2024-05	0	1.62
2024-06	0	1.86
2024-07	0	1.56
2024-08	0	1.68
2024-09	0	1.64
2024-10	0	1.67
2024-11	0	1.55
2024-12	0	1.57
2025-01	0	1.68
2025-02	0	1.58
2025-03	0	1.85
2025-04	0	1.64
2025-05	0	1.74
2025-06	0	1.86
2025-07	0	1.72
2025-08	0	1.57
2025-09	0	1.47
2025-10	0	1.6
2025-11	0	1.73
2025-12	0	2.16
2026-01	1	1.87
2026-02	0	1.79
2026-03	0	1.7
2026-04	0	1.72
2026-05	0	1.69
2026-06	0	1.73

This device (reports/month)Average device in HSD, KWS, MBF, PHX (reports/device/month)

Regulatory clearances

K101996 SESE 2010-12-15 (k number procode)

Predicate lineage

K101996 — cited as predicate by K170748, K170910, K202098, K212710

K170748 — cites (transitively): K052906 (d1), K060704 (d1), K062250 (d1), K071379 (d1), K101996 (d1), K133834 (d1) — cited as predicate by K191433, K192855, K202098, K203694, K211553, K212710

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