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Unnamed device

Model 2358-13-04 · Zimmer, Inc. · DI 00889024056428

HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030

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.

12342019-01: 0 reports for this device; peer average 1.94/device2019-02: 0 reports for this device; peer average 1.56/device2019-03: 0 reports for this device; peer average 1.88/device2019-04: 0 reports for this device; peer average 2.36/device2019-05: 0 reports for this device; peer average 1.69/device2019-06: 0 reports for this device; peer average 1.64/device2019-07: 0 reports for this device; peer average 1.68/device2019-08: 0 reports for this device; peer average 1.54/device2019-09: 0 reports for this device; peer average 1.66/device2019-10: 0 reports for this device; peer average 1.53/device2019-11: 0 reports for this device; peer average 1.8/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 2.19/device2020-02: 0 reports for this device; peer average 1.28/device2020-03: 0 reports for this device; peer average 1.64/device2020-04: 0 reports for this device; peer average 1.95/device2020-05: 0 reports for this device; peer average 1.79/device2020-06: 0 reports for this device; peer average 1.92/device2020-07: 0 reports for this device; peer average 1.93/device2020-08: 0 reports for this device; peer average 2.34/device2020-09: 0 reports for this device; peer average 2.75/device2020-10: 0 reports for this device; peer average 1.95/device2020-11: 0 reports for this device; peer average 2.34/device2020-12: 0 reports for this device; peer average 2.26/device2021-01: 0 reports for this device; peer average 1.79/device2021-02: 0 reports for this device; peer average 1.94/device2021-03: 0 reports for this device; peer average 2.13/device2021-04: 0 reports for this device; peer average 2.85/device2021-05: 0 reports for this device; peer average 2.64/device2021-06: 0 reports for this device; peer average 2.05/device2021-07: 0 reports for this device; peer average 2.28/device2021-08: 0 reports for this device; peer average 1.87/device2021-09: 0 reports for this device; peer average 2.04/device2021-10: 0 reports for this device; peer average 2.02/device2021-11: 0 reports for this device; peer average 2.05/device2021-12: 0 reports for this device; peer average 2.21/device2022-01: 0 reports for this device; peer average 2.88/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1.65/device2022-04: 0 reports for this device; peer average 2.04/device2022-05: 0 reports for this device; peer average 1.96/device2022-06: 0 reports for this device; peer average 2.35/device2022-07: 0 reports for this device; peer average 2.26/device2022-08: 0 reports for this device; peer average 2.01/device2022-09: 0 reports for this device; peer average 2.39/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 2.93/device2022-12: 0 reports for this device; peer average 2.83/device2023-01: 0 reports for this device; peer average 2.51/device2023-02: 0 reports for this device; peer average 2.57/device2023-03: 0 reports for this device; peer average 2.98/device2023-04: 0 reports for this device; peer average 3.11/device2023-05: 0 reports for this device; peer average 4.19/device2023-06: 0 reports for this device; peer average 2.96/device2023-07: 0 reports for this device; peer average 2.23/device2023-08: 0 reports for this device; peer average 2.22/device2023-09: 0 reports for this device; peer average 2.08/device2023-10: 0 reports for this device; peer average 2.45/device2023-11: 0 reports for this device; peer average 2.03/device2023-12: 0 reports for this device; peer average 2.42/device2024-01: 0 reports for this device; peer average 2.06/device2024-02: 0 reports for this device; peer average 1.72/device2024-03: 0 reports for this device; peer average 1.82/device2024-04: 0 reports for this device; peer average 2.09/device2024-05: 0 reports for this device; peer average 1.95/device2024-06: 0 reports for this device; peer average 2.35/device2024-07: 0 reports for this device; peer average 2.23/device2024-08: 0 reports for this device; peer average 2.28/device2024-09: 0 reports for this device; peer average 1.66/device2024-10: 0 reports for this device; peer average 2.32/device2024-11: 0 reports for this device; peer average 1.61/device2024-12: 0 reports for this device; peer average 2.88/device2025-01: 0 reports for this device; peer average 1.62/device2025-02: 0 reports for this device; peer average 1.76/device2025-03: 0 reports for this device; peer average 2.68/device2025-04: 0 reports for this device; peer average 1.82/device2025-05: 0 reports for this device; peer average 2.08/device2025-06: 0 reports for this device; peer average 1.73/device2025-07: 0 reports for this device; peer average 2.09/device2025-08: 0 reports for this device; peer average 2.1/device2025-09: 0 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 2.08/device2025-11: 0 reports for this device; peer average 1.92/device2025-12: 0 reports for this device; peer average 2.46/device2026-01: 0 reports for this device; peer average 1.7/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 3.1/device2026-04: 0 reports for this device; peer average 2.2/device2026-05: 0 reports for this device; peer average 2.03/device2026-06: 0 reports for this device; peer average 1.84/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.94
2019-0201.56
2019-0301.88
2019-0402.36
2019-0501.69
2019-0601.64
2019-0701.68
2019-0801.54
2019-0901.66
2019-1001.53
2019-1101.8
2019-1202
2020-0102.19
2020-0201.28
2020-0301.64
2020-0401.95
2020-0501.79
2020-0601.92
2020-0701.93
2020-0802.34
2020-0902.75
2020-1001.95
2020-1102.34
2020-1202.26
2021-0101.79
2021-0201.94
2021-0302.13
2021-0402.85
2021-0502.64
2021-0602.05
2021-0702.28
2021-0801.87
2021-0902.04
2021-1002.02
2021-1102.05
2021-1202.21
2022-0102.88
2022-0202
2022-0301.65
2022-0402.04
2022-0501.96
2022-0602.35
2022-0702.26
2022-0802.01
2022-0902.39
2022-1003
2022-1102.93
2022-1202.83
2023-0102.51
2023-0202.57
2023-0302.98
2023-0403.11
2023-0504.19
2023-0602.96
2023-0702.23
2023-0802.22
2023-0902.08
2023-1002.45
2023-1102.03
2023-1202.42
2024-0102.06
2024-0201.72
2024-0301.82
2024-0402.09
2024-0501.95
2024-0602.35
2024-0702.23
2024-0802.28
2024-0901.66
2024-1002.32
2024-1101.61
2024-1202.88
2025-0101.62
2025-0201.76
2025-0302.68
2025-0401.82
2025-0502.08
2025-0601.73
2025-0702.09
2025-0802.1
2025-0901.75
2025-1002.08
2025-1101.92
2025-1202.46
2026-0101.7
2026-0202
2026-0303.1
2026-0402.2
2026-0502.03
2026-0601.84
This device (reports/month)Average device in HRS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K040593 — cited as predicate by K100271, K111039, K121601, K133246, K142938, K152242, K161058

K141734 — cites (transitively): K042598 (d1), K082078 (d1), K111039 (d1), K040593 (d2), K043227 (d2), K043560 (d2), K050121 (d2), K051098 (d2)

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

Manufacturer compliance record — Zimmer, Inc.

  • 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