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Anatomical Shoulder™ Reverse

Model 01.04223.111 · Zimmer GmbH · DI 00889024286085

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

KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650

UDILibrary device dossier · generated 2026-09-07 · 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.

11222019-01: 0 reports for this device; peer average 1.74/device2019-02: 0 reports for this device; peer average 1.55/device2019-03: 0 reports for this device; peer average 1.6/device2019-04: 0 reports for this device; peer average 1.72/device2019-05: 0 reports for this device; peer average 1.87/device2019-06: 0 reports for this device; peer average 1.88/device2019-07: 0 reports for this device; peer average 1.47/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1.52/device2019-10: 0 reports for this device; peer average 1.86/device2019-11: 0 reports for this device; peer average 1.58/device2019-12: 0 reports for this device; peer average 1.8/device2020-01: 0 reports for this device; peer average 1.87/device2020-02: 0 reports for this device; peer average 2.13/device2020-03: 0 reports for this device; peer average 1.77/device2020-04: 0 reports for this device; peer average 1.67/device2020-05: 0 reports for this device; peer average 1.55/device2020-06: 0 reports for this device; peer average 1.98/device2020-07: 0 reports for this device; peer average 1.91/device2020-08: 0 reports for this device; peer average 1.79/device2020-09: 0 reports for this device; peer average 2.01/device2020-10: 0 reports for this device; peer average 2.2/device2020-11: 0 reports for this device; peer average 1.94/device2020-12: 0 reports for this device; peer average 1.84/device2021-01: 0 reports for this device; peer average 1.95/device2021-02: 0 reports for this device; peer average 1.74/device2021-03: 0 reports for this device; peer average 1.93/device2021-04: 0 reports for this device; peer average 1.82/device2021-05: 0 reports for this device; peer average 1.66/device2021-06: 0 reports for this device; peer average 1.58/device2021-07: 0 reports for this device; peer average 1.97/device2021-08: 0 reports for this device; peer average 2.12/device2021-09: 0 reports for this device; peer average 1.72/device2021-10: 0 reports for this device; peer average 1.81/device2021-11: 0 reports for this device; peer average 1.93/device2021-12: 0 reports for this device; peer average 2.02/device2022-01: 0 reports for this device; peer average 2.08/device2022-02: 0 reports for this device; peer average 2.17/device2022-03: 0 reports for this device; peer average 1.87/device2022-04: 0 reports for this device; peer average 2.07/device2022-05: 0 reports for this device; peer average 1.83/device2022-06: 0 reports for this device; peer average 2.17/device2022-07: 0 reports for this device; peer average 2.1/device2022-08: 0 reports for this device; peer average 2.02/device2022-09: 0 reports for this device; peer average 1.88/device2022-10: 0 reports for this device; peer average 1.8/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1.86/device2023-01: 0 reports for this device; peer average 1.72/device2023-02: 0 reports for this device; peer average 1.87/device2023-03: 0 reports for this device; peer average 1.85/device2023-04: 0 reports for this device; peer average 1.86/device2023-05: 0 reports for this device; peer average 1.93/device2023-06: 0 reports for this device; peer average 2.13/device2023-07: 0 reports for this device; peer average 2.05/device2023-08: 0 reports for this device; peer average 1.67/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 0 reports for this device; peer average 1.53/device2023-11: 0 reports for this device; peer average 1.62/device2023-12: 0 reports for this device; peer average 1.4/device2024-01: 0 reports for this device; peer average 1.9/device2024-02: 0 reports for this device; peer average 1.83/device2024-03: 0 reports for this device; peer average 1.67/device2024-04: 0 reports for this device; peer average 1.8/device2024-05: 0 reports for this device; peer average 1.71/device2024-06: 0 reports for this device; peer average 1.89/device2024-07: 0 reports for this device; peer average 1.6/device2024-08: 0 reports for this device; peer average 1.68/device2024-09: 0 reports for this device; peer average 1.74/device2024-10: 0 reports for this device; peer average 1.65/device2024-11: 0 reports for this device; peer average 1.65/device2024-12: 0 reports for this device; peer average 1.7/device2025-01: 0 reports for this device; peer average 1.74/device2025-02: 0 reports for this device; peer average 1.63/device2025-03: 0 reports for this device; peer average 1.82/device2025-04: 0 reports for this device; peer average 1.79/device2025-05: 0 reports for this device; peer average 1.88/device2025-06: 0 reports for this device; peer average 1.83/device2025-07: 0 reports for this device; peer average 1.65/device2025-08: 0 reports for this device; peer average 1.64/device2025-09: 0 reports for this device; peer average 1.46/device2025-10: 0 reports for this device; peer average 1.6/device2025-11: 0 reports for this device; peer average 1.71/device2025-12: 0 reports for this device; peer average 2.09/device2026-01: 0 reports for this device; peer average 1.84/device2026-02: 0 reports for this device; peer average 1.72/device2026-03: 0 reports for this device; peer average 1.73/device2026-04: 0 reports for this device; peer average 1.71/device2026-05: 0 reports for this device; peer average 1.7/device2026-06: 0 reports for this device; peer average 1.64/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.74
2019-0201.55
2019-0301.6
2019-0401.72
2019-0501.87
2019-0601.88
2019-0701.47
2019-0802
2019-0901.52
2019-1001.86
2019-1101.58
2019-1201.8
2020-0101.87
2020-0202.13
2020-0301.77
2020-0401.67
2020-0501.55
2020-0601.98
2020-0701.91
2020-0801.79
2020-0902.01
2020-1002.2
2020-1101.94
2020-1201.84
2021-0101.95
2021-0201.74
2021-0301.93
2021-0401.82
2021-0501.66
2021-0601.58
2021-0701.97
2021-0802.12
2021-0901.72
2021-1001.81
2021-1101.93
2021-1202.02
2022-0102.08
2022-0202.17
2022-0301.87
2022-0402.07
2022-0501.83
2022-0602.17
2022-0702.1
2022-0802.02
2022-0901.88
2022-1001.8
2022-1102
2022-1201.86
2023-0101.72
2023-0201.87
2023-0301.85
2023-0401.86
2023-0501.93
2023-0602.13
2023-0702.05
2023-0801.67
2023-0901.5
2023-1001.53
2023-1101.62
2023-1201.4
2024-0101.9
2024-0201.83
2024-0301.67
2024-0401.8
2024-0501.71
2024-0601.89
2024-0701.6
2024-0801.68
2024-0901.74
2024-1001.65
2024-1101.65
2024-1201.7
2025-0101.74
2025-0201.63
2025-0301.82
2025-0401.79
2025-0501.88
2025-0601.83
2025-0701.65
2025-0801.64
2025-0901.46
2025-1001.6
2025-1101.71
2025-1202.09
2026-0101.84
2026-0201.72
2026-0301.73
2026-0401.71
2026-0501.7
2026-0601.64
This device (reports/month)Average device in KWS, KWT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K053274 — cited as predicate by K142139, K142863, K150488, K170711, K172371, K181287

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

Manufacturer compliance record — Zimmer GmbH

  • Warning Letter 2016-05-27 Orthosoft, Inc.
  • Warning Letter 2012-09-19 Zimmer Manufacturing B.V.
  • NAI 2022-07-27 Zimmer, Inc. · 0 citations
  • NAI 2022-07-27 Zimmer, Inc. · 0 citations
  • NAI 2020-10-01 Zimmer Manufacturing B.V. · 0 citations
  • VAI 2017-10-16 Zimmer, Inc. · 8 citations
  • VAI 2017-10-16 Zimmer, Inc. · 8 citations
  • NAI 2017-09-01 Zimmer Trabecular Metal Technology, Inc. · 0 citations
  • VAI 2017-07-27 ZIMMER ORTHOPEDIC MFG LTD · 3 citations
  • VAI 2017-07-20 Zimmer Manufacturing B.V. · 3 citations
  • VAI 2016-05-23 Zimmer Surgical Inc · 4 citations
  • OAI 2015-11-20 Zimmer, Inc. · 10 citations
  • OAI 2015-11-20 Zimmer, Inc. · 10 citations
  • VAI 2015-11-17 Zimmer Manufacturing B.V. · 4 citations
  • VAI 2015-05-11 Zimmer Trabecular Metal Technology, Inc. · 3 citations
  • VAI 2014-10-16 ZIMMER ORTHOPEDIC MFG LTD · 2 citations
  • OAI 2014-06-11 Zimmer Manufacturing B.V. · 9 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • OAI 2013-08-19 Zimmer, Inc. · 0 citations