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12/13 PSN 4N1 SPACER BLOCK

Model SSI007267 · Zimmer, Inc. · DI 00889024657922

FZX — Guide, Surgical, Instrument · Class I · 21 CFR 878.4800

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.

11232019-01: 0 reports for this device; peer average 1.58/device2019-02: 0 reports for this device; peer average 1.1/device2019-03: 0 reports for this device; peer average 1.13/device2019-04: 0 reports for this device; peer average 1.32/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 1.26/device2019-07: 0 reports for this device; peer average 1.38/device2019-08: 0 reports for this device; peer average 1.34/device2019-09: 0 reports for this device; peer average 1.38/device2019-10: 0 reports for this device; peer average 1.82/device2019-11: 0 reports for this device; peer average 1.48/device2019-12: 0 reports for this device; peer average 1.27/device2020-01: 0 reports for this device; peer average 1.68/device2020-02: 0 reports for this device; peer average 1.36/device2020-03: 0 reports for this device; peer average 1.74/device2020-04: 0 reports for this device; peer average 1.61/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 1.28/device2020-07: 0 reports for this device; peer average 2.03/device2020-08: 0 reports for this device; peer average 1.89/device2020-09: 0 reports for this device; peer average 1.73/device2020-10: 0 reports for this device; peer average 2.02/device2020-11: 0 reports for this device; peer average 1.91/device2020-12: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 2.03/device2021-02: 0 reports for this device; peer average 2.21/device2021-03: 0 reports for this device; peer average 1.54/device2021-04: 0 reports for this device; peer average 2.83/device2021-05: 0 reports for this device; peer average 2.91/device2021-06: 0 reports for this device; peer average 1.75/device2021-07: 0 reports for this device; peer average 1.63/device2021-08: 0 reports for this device; peer average 1.63/device2021-09: 0 reports for this device; peer average 1.62/device2021-10: 0 reports for this device; peer average 1.77/device2021-11: 0 reports for this device; peer average 2.05/device2021-12: 0 reports for this device; peer average 1.43/device2022-01: 0 reports for this device; peer average 1.4/device2022-02: 0 reports for this device; peer average 1.98/device2022-03: 0 reports for this device; peer average 1.83/device2022-04: 0 reports for this device; peer average 1.37/device2022-05: 0 reports for this device; peer average 1.62/device2022-06: 0 reports for this device; peer average 1.57/device2022-07: 0 reports for this device; peer average 2.17/device2022-08: 0 reports for this device; peer average 1.52/device2022-09: 0 reports for this device; peer average 1.78/device2022-10: 0 reports for this device; peer average 1.65/device2022-11: 0 reports for this device; peer average 1.9/device2022-12: 0 reports for this device; peer average 1.4/device2023-01: 0 reports for this device; peer average 2.44/device2023-02: 0 reports for this device; peer average 2.17/device2023-03: 0 reports for this device; peer average 2.09/device2023-04: 0 reports for this device; peer average 2.45/device2023-05: 0 reports for this device; peer average 2.51/device2023-06: 0 reports for this device; peer average 2.6/device2023-07: 0 reports for this device; peer average 1.92/device2023-08: 0 reports for this device; peer average 1.43/device2023-09: 0 reports for this device; peer average 1.4/device2023-10: 0 reports for this device; peer average 1.37/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 1.75/device2024-01: 0 reports for this device; peer average 1.39/device2024-02: 0 reports for this device; peer average 2.08/device2024-03: 0 reports for this device; peer average 1.43/device2024-04: 0 reports for this device; peer average 1.29/device2024-05: 0 reports for this device; peer average 1.44/device2024-06: 0 reports for this device; peer average 1.61/device2024-07: 0 reports for this device; peer average 1.56/device2024-08: 0 reports for this device; peer average 1.82/device2024-09: 0 reports for this device; peer average 1.91/device2024-10: 0 reports for this device; peer average 1.33/device2024-11: 0 reports for this device; peer average 1.46/device2024-12: 0 reports for this device; peer average 1.44/device2025-01: 0 reports for this device; peer average 1.46/device2025-02: 0 reports for this device; peer average 1.29/device2025-03: 0 reports for this device; peer average 1.34/device2025-04: 0 reports for this device; peer average 1.72/device2025-05: 0 reports for this device; peer average 1.33/device2025-06: 0 reports for this device; peer average 1.3/device2025-07: 0 reports for this device; peer average 1.36/device2025-08: 0 reports for this device; peer average 1.94/device2025-09: 0 reports for this device; peer average 1.45/device2025-10: 0 reports for this device; peer average 1.2/device2025-11: 0 reports for this device; peer average 1.52/device2025-12: 0 reports for this device; peer average 1.58/device2026-01: 0 reports for this device; peer average 1.74/device2026-02: 0 reports for this device; peer average 1.65/device2026-03: 0 reports for this device; peer average 1.67/device2026-04: 0 reports for this device; peer average 1.41/device2026-05: 0 reports for this device; peer average 1.47/device2026-06: 0 reports for this device; peer average 1.42/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.58
2019-0201.1
2019-0301.13
2019-0401.32
2019-0501.5
2019-0601.26
2019-0701.38
2019-0801.34
2019-0901.38
2019-1001.82
2019-1101.48
2019-1201.27
2020-0101.68
2020-0201.36
2020-0301.74
2020-0401.61
2020-0501.5
2020-0601.28
2020-0702.03
2020-0801.89
2020-0901.73
2020-1002.02
2020-1101.91
2020-1202.07
2021-0102.03
2021-0202.21
2021-0301.54
2021-0402.83
2021-0502.91
2021-0601.75
2021-0701.63
2021-0801.63
2021-0901.62
2021-1001.77
2021-1102.05
2021-1201.43
2022-0101.4
2022-0201.98
2022-0301.83
2022-0401.37
2022-0501.62
2022-0601.57
2022-0702.17
2022-0801.52
2022-0901.78
2022-1001.65
2022-1101.9
2022-1201.4
2023-0102.44
2023-0202.17
2023-0302.09
2023-0402.45
2023-0502.51
2023-0602.6
2023-0701.92
2023-0801.43
2023-0901.4
2023-1001.37
2023-1101.5
2023-1201.75
2024-0101.39
2024-0202.08
2024-0301.43
2024-0401.29
2024-0501.44
2024-0601.61
2024-0701.56
2024-0801.82
2024-0901.91
2024-1001.33
2024-1101.46
2024-1201.44
2025-0101.46
2025-0201.29
2025-0301.34
2025-0401.72
2025-0501.33
2025-0601.3
2025-0701.36
2025-0801.94
2025-0901.45
2025-1001.2
2025-1101.52
2025-1201.58
2026-0101.74
2026-0201.65
2026-0301.67
2026-0401.41
2026-0501.47
2026-0601.42
This device (reports/month)Average device in FZX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

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