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Affixus® Natural Nail®

Model 47-2486-046-40 · Zimmer GmbH · DI 00889024505476

HSB — Rod, Fixation, Intramedullary And Accessories · Class II · 21 CFR 888.3020

UDILibrary device dossier · generated 2026-09-12 · 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 (58)

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: 54 · Malfunction: 4

24682019-01: 0 reports for this device; peer average 1.41/device2019-02: 0 reports for this device; peer average 1.44/device2019-03: 0 reports for this device; peer average 1.62/device2019-04: 0 reports for this device; peer average 1.4/device2019-05: 0 reports for this device; peer average 1.35/device2019-06: 0 reports for this device; peer average 1.56/device2019-07: 0 reports for this device; peer average 1.47/device2019-08: 0 reports for this device; peer average 1.71/device2019-09: 0 reports for this device; peer average 1.4/device2019-10: 0 reports for this device; peer average 1.44/device2019-11: 0 reports for this device; peer average 1.67/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 1 reports for this device; peer average 1.53/device2020-02: 0 reports for this device; peer average 1.4/device2020-03: 0 reports for this device; peer average 1.43/device2020-04: 0 reports for this device; peer average 1.96/device2020-05: 0 reports for this device; peer average 1.84/device2020-06: 1 reports for this device; peer average 2.15/device2020-07: 0 reports for this device; peer average 2.29/device2020-08: 0 reports for this device; peer average 3.06/device2020-09: 0 reports for this device; peer average 2.11/device2020-10: 1 reports for this device; peer average 2.5/device2020-11: 0 reports for this device; peer average 3.28/device2020-12: 2 reports for this device; peer average 3.43/device2021-01: 1 reports for this device; peer average 3.12/device2021-02: 1 reports for this device; peer average 3.06/device2021-03: 1 reports for this device; peer average 3.26/device2021-04: 0 reports for this device; peer average 3.44/device2021-05: 2 reports for this device; peer average 4.35/device2021-06: 2 reports for this device; peer average 3.12/device2021-07: 1 reports for this device; peer average 2.45/device2021-08: 4 reports for this device; peer average 2.05/device2021-09: 2 reports for this device; peer average 2.24/device2021-10: 0 reports for this device; peer average 1.74/device2021-11: 0 reports for this device; peer average 3.41/device2021-12: 0 reports for this device; peer average 2.36/device2022-01: 0 reports for this device; peer average 2.92/device2022-02: 8 reports for this device; peer average 2.06/device2022-03: 0 reports for this device; peer average 2.25/device2022-04: 3 reports for this device; peer average 2.35/device2022-05: 1 reports for this device; peer average 2.06/device2022-06: 2 reports for this device; peer average 2.2/device2022-07: 1 reports for this device; peer average 1.78/device2022-08: 1 reports for this device; peer average 1.88/device2022-09: 2 reports for this device; peer average 2.28/device2022-10: 1 reports for this device; peer average 2.35/device2022-11: 1 reports for this device; peer average 2.23/device2022-12: 0 reports for this device; peer average 2.13/device2023-01: 2 reports for this device; peer average 2.14/device2023-02: 3 reports for this device; peer average 2.19/device2023-03: 1 reports for this device; peer average 2.56/device2023-04: 0 reports for this device; peer average 2.33/device2023-05: 0 reports for this device; peer average 2.56/device2023-06: 0 reports for this device; peer average 2.56/device2023-07: 0 reports for this device; peer average 1.93/device2023-08: 0 reports for this device; peer average 1.68/device2023-09: 0 reports for this device; peer average 1.41/device2023-10: 0 reports for this device; peer average 1.43/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 1.51/device2024-01: 0 reports for this device; peer average 1.56/device2024-02: 0 reports for this device; peer average 1.42/device2024-03: 0 reports for this device; peer average 1.7/device2024-04: 0 reports for this device; peer average 1.4/device2024-05: 0 reports for this device; peer average 1.7/device2024-06: 0 reports for this device; peer average 1.71/device2024-07: 0 reports for this device; peer average 1.43/device2024-08: 0 reports for this device; peer average 1.92/device2024-09: 2 reports for this device; peer average 2.2/device2024-10: 1 reports for this device; peer average 1.64/device2024-11: 0 reports for this device; peer average 1.51/device2024-12: 0 reports for this device; peer average 1.62/device2025-01: 0 reports for this device; peer average 1.66/device2025-02: 0 reports for this device; peer average 1.51/device2025-03: 1 reports for this device; peer average 1.53/device2025-04: 3 reports for this device; peer average 1.54/device2025-05: 1 reports for this device; peer average 1.51/device2025-06: 0 reports for this device; peer average 1.43/device2025-07: 0 reports for this device; peer average 1.54/device2025-08: 0 reports for this device; peer average 1.48/device2025-09: 1 reports for this device; peer average 1.38/device2025-10: 0 reports for this device; peer average 1.61/device2025-11: 2 reports for this device; peer average 1.75/device2025-12: 0 reports for this device; peer average 1.77/device2026-01: 0 reports for this device; peer average 1.85/device2026-02: 1 reports for this device; peer average 1.47/device2026-03: 0 reports for this device; peer average 1.77/device2026-04: 0 reports for this device; peer average 1.6/device2026-05: 0 reports for this device; peer average 1.67/device2026-06: 1 reports for this device; peer average 1.59/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.41
2019-0201.44
2019-0301.62
2019-0401.4
2019-0501.35
2019-0601.56
2019-0701.47
2019-0801.71
2019-0901.4
2019-1001.44
2019-1101.67
2019-1201.5
2020-0111.53
2020-0201.4
2020-0301.43
2020-0401.96
2020-0501.84
2020-0612.15
2020-0702.29
2020-0803.06
2020-0902.11
2020-1012.5
2020-1103.28
2020-1223.43
2021-0113.12
2021-0213.06
2021-0313.26
2021-0403.44
2021-0524.35
2021-0623.12
2021-0712.45
2021-0842.05
2021-0922.24
2021-1001.74
2021-1103.41
2021-1202.36
2022-0102.92
2022-0282.06
2022-0302.25
2022-0432.35
2022-0512.06
2022-0622.2
2022-0711.78
2022-0811.88
2022-0922.28
2022-1012.35
2022-1112.23
2022-1202.13
2023-0122.14
2023-0232.19
2023-0312.56
2023-0402.33
2023-0502.56
2023-0602.56
2023-0701.93
2023-0801.68
2023-0901.41
2023-1001.43
2023-1101.5
2023-1201.51
2024-0101.56
2024-0201.42
2024-0301.7
2024-0401.4
2024-0501.7
2024-0601.71
2024-0701.43
2024-0801.92
2024-0922.2
2024-1011.64
2024-1101.51
2024-1201.62
2025-0101.66
2025-0201.51
2025-0311.53
2025-0431.54
2025-0511.51
2025-0601.43
2025-0701.54
2025-0801.48
2025-0911.38
2025-1001.61
2025-1121.75
2025-1201.77
2026-0101.85
2026-0211.47
2026-0301.77
2026-0401.6
2026-0501.67
2026-0611.59
This device (reports/month)Average device in HSB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

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