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Unnamed device

Model 47-4835-120-01 · Zimmer, Inc. · DI 00889024101661

HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040

UDILibrary device dossier · generated 2026-09-14 · 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.

13452019-01: 0 reports for this device; peer average 2.11/device2019-02: 0 reports for this device; peer average 1.6/device2019-03: 0 reports for this device; peer average 1.65/device2019-04: 0 reports for this device; peer average 2.23/device2019-05: 0 reports for this device; peer average 1.75/device2019-06: 0 reports for this device; peer average 1.81/device2019-07: 0 reports for this device; peer average 2.06/device2019-08: 0 reports for this device; peer average 2.03/device2019-09: 0 reports for this device; peer average 1.75/device2019-10: 0 reports for this device; peer average 1.69/device2019-11: 0 reports for this device; peer average 1.96/device2019-12: 0 reports for this device; peer average 2.52/device2020-01: 0 reports for this device; peer average 2.55/device2020-02: 0 reports for this device; peer average 2.13/device2020-03: 0 reports for this device; peer average 1.9/device2020-04: 0 reports for this device; peer average 1.87/device2020-05: 0 reports for this device; peer average 1.75/device2020-06: 0 reports for this device; peer average 2.06/device2020-07: 0 reports for this device; peer average 2.67/device2020-08: 0 reports for this device; peer average 2.5/device2020-09: 0 reports for this device; peer average 2.44/device2020-10: 0 reports for this device; peer average 2.22/device2020-11: 0 reports for this device; peer average 2.83/device2020-12: 0 reports for this device; peer average 2.48/device2021-01: 0 reports for this device; peer average 1.85/device2021-02: 0 reports for this device; peer average 2.29/device2021-03: 0 reports for this device; peer average 2.59/device2021-04: 0 reports for this device; peer average 2.7/device2021-05: 0 reports for this device; peer average 2.4/device2021-06: 0 reports for this device; peer average 2.2/device2021-07: 0 reports for this device; peer average 2.29/device2021-08: 0 reports for this device; peer average 2.07/device2021-09: 0 reports for this device; peer average 2.36/device2021-10: 0 reports for this device; peer average 2.08/device2021-11: 0 reports for this device; peer average 2.26/device2021-12: 0 reports for this device; peer average 2.35/device2022-01: 0 reports for this device; peer average 2.94/device2022-02: 0 reports for this device; peer average 2.2/device2022-03: 0 reports for this device; peer average 2.01/device2022-04: 0 reports for this device; peer average 1.94/device2022-05: 0 reports for this device; peer average 2.37/device2022-06: 0 reports for this device; peer average 2.22/device2022-07: 0 reports for this device; peer average 2.18/device2022-08: 0 reports for this device; peer average 2.48/device2022-09: 0 reports for this device; peer average 2.88/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 2.99/device2022-12: 0 reports for this device; peer average 5.49/device2023-01: 0 reports for this device; peer average 2.72/device2023-02: 0 reports for this device; peer average 2.85/device2023-03: 0 reports for this device; peer average 3.08/device2023-04: 0 reports for this device; peer average 2.76/device2023-05: 0 reports for this device; peer average 3.3/device2023-06: 0 reports for this device; peer average 2.94/device2023-07: 0 reports for this device; peer average 2.28/device2023-08: 0 reports for this device; peer average 2.16/device2023-09: 0 reports for this device; peer average 2.02/device2023-10: 0 reports for this device; peer average 2.14/device2023-11: 0 reports for this device; peer average 1.87/device2023-12: 0 reports for this device; peer average 2.44/device2024-01: 0 reports for this device; peer average 2.76/device2024-02: 0 reports for this device; peer average 1.81/device2024-03: 0 reports for this device; peer average 2.34/device2024-04: 0 reports for this device; peer average 2.12/device2024-05: 0 reports for this device; peer average 2.3/device2024-06: 0 reports for this device; peer average 2.26/device2024-07: 0 reports for this device; peer average 2.46/device2024-08: 0 reports for this device; peer average 2.14/device2024-09: 0 reports for this device; peer average 2.15/device2024-10: 0 reports for this device; peer average 2.19/device2024-11: 0 reports for this device; peer average 2.05/device2024-12: 0 reports for this device; peer average 2.76/device2025-01: 0 reports for this device; peer average 2.2/device2025-02: 0 reports for this device; peer average 2.18/device2025-03: 0 reports for this device; peer average 2.06/device2025-04: 0 reports for this device; peer average 2.54/device2025-05: 0 reports for this device; peer average 2.49/device2025-06: 0 reports for this device; peer average 2.01/device2025-07: 0 reports for this device; peer average 2.14/device2025-08: 0 reports for this device; peer average 2.39/device2025-09: 0 reports for this device; peer average 2.07/device2025-10: 0 reports for this device; peer average 2.47/device2025-11: 0 reports for this device; peer average 2.05/device2025-12: 0 reports for this device; peer average 2.73/device2026-01: 0 reports for this device; peer average 2.06/device2026-02: 0 reports for this device; peer average 2.37/device2026-03: 0 reports for this device; peer average 2.62/device2026-04: 0 reports for this device; peer average 2.17/device2026-05: 0 reports for this device; peer average 2.56/device2026-06: 0 reports for this device; peer average 2.32/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.11
2019-0201.6
2019-0301.65
2019-0402.23
2019-0501.75
2019-0601.81
2019-0702.06
2019-0802.03
2019-0901.75
2019-1001.69
2019-1101.96
2019-1202.52
2020-0102.55
2020-0202.13
2020-0301.9
2020-0401.87
2020-0501.75
2020-0602.06
2020-0702.67
2020-0802.5
2020-0902.44
2020-1002.22
2020-1102.83
2020-1202.48
2021-0101.85
2021-0202.29
2021-0302.59
2021-0402.7
2021-0502.4
2021-0602.2
2021-0702.29
2021-0802.07
2021-0902.36
2021-1002.08
2021-1102.26
2021-1202.35
2022-0102.94
2022-0202.2
2022-0302.01
2022-0401.94
2022-0502.37
2022-0602.22
2022-0702.18
2022-0802.48
2022-0902.88
2022-1003
2022-1102.99
2022-1205.49
2023-0102.72
2023-0202.85
2023-0303.08
2023-0402.76
2023-0503.3
2023-0602.94
2023-0702.28
2023-0802.16
2023-0902.02
2023-1002.14
2023-1101.87
2023-1202.44
2024-0102.76
2024-0201.81
2024-0302.34
2024-0402.12
2024-0502.3
2024-0602.26
2024-0702.46
2024-0802.14
2024-0902.15
2024-1002.19
2024-1102.05
2024-1202.76
2025-0102.2
2025-0202.18
2025-0302.06
2025-0402.54
2025-0502.49
2025-0602.01
2025-0702.14
2025-0802.39
2025-0902.07
2025-1002.47
2025-1102.05
2025-1202.73
2026-0102.06
2026-0202.37
2026-0302.62
2026-0402.17
2026-0502.56
2026-0602.32
This device (reports/month)Average device in HWC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K112885 — cites (transitively): K003496 (d1), K063303 (d1), K082527 (d1), K090047 (d1), K952272 (d1), K983265 (d1) — cited as predicate by K140508, K142836, K143039

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