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39MM BRIDGEBACK RMR

Model SSI006800 · Zimmer, Inc. · DI 00889024645820

HWR — Driver, Prosthesis · Class I · 21 CFR 888.4540

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.

24682019-01: 0 reports for this device; peer average 5.38/device2019-02: 0 reports for this device; peer average 5.13/device2019-03: 0 reports for this device; peer average 3.47/device2019-04: 0 reports for this device; peer average 5.67/device2019-05: 0 reports for this device; peer average 4.9/device2019-06: 0 reports for this device; peer average 4.6/device2019-07: 0 reports for this device; peer average 4.26/device2019-08: 0 reports for this device; peer average 3.77/device2019-09: 0 reports for this device; peer average 3.47/device2019-10: 0 reports for this device; peer average 3.38/device2019-11: 0 reports for this device; peer average 4.86/device2019-12: 0 reports for this device; peer average 4.13/device2020-01: 0 reports for this device; peer average 4.92/device2020-02: 0 reports for this device; peer average 3.07/device2020-03: 0 reports for this device; peer average 4.94/device2020-04: 0 reports for this device; peer average 2.54/device2020-05: 0 reports for this device; peer average 3.07/device2020-06: 0 reports for this device; peer average 4.33/device2020-07: 0 reports for this device; peer average 3.28/device2020-08: 0 reports for this device; peer average 3.36/device2020-09: 0 reports for this device; peer average 4.41/device2020-10: 0 reports for this device; peer average 5/device2020-11: 0 reports for this device; peer average 5.43/device2020-12: 0 reports for this device; peer average 5.61/device2021-01: 0 reports for this device; peer average 3.89/device2021-02: 0 reports for this device; peer average 4.5/device2021-03: 0 reports for this device; peer average 5.42/device2021-04: 0 reports for this device; peer average 4.39/device2021-05: 0 reports for this device; peer average 4.38/device2021-06: 0 reports for this device; peer average 3.74/device2021-07: 0 reports for this device; peer average 4.4/device2021-08: 0 reports for this device; peer average 6/device2021-09: 0 reports for this device; peer average 3.3/device2021-10: 0 reports for this device; peer average 3.22/device2021-11: 0 reports for this device; peer average 5.09/device2021-12: 0 reports for this device; peer average 4.04/device2022-01: 0 reports for this device; peer average 3.37/device2022-02: 0 reports for this device; peer average 3.21/device2022-03: 0 reports for this device; peer average 6.82/device2022-04: 0 reports for this device; peer average 5.6/device2022-05: 0 reports for this device; peer average 3.58/device2022-06: 0 reports for this device; peer average 4.58/device2022-07: 0 reports for this device; peer average 4/device2022-08: 0 reports for this device; peer average 5.72/device2022-09: 0 reports for this device; peer average 4.8/device2022-10: 0 reports for this device; peer average 4.27/device2022-11: 0 reports for this device; peer average 6.11/device2022-12: 0 reports for this device; peer average 4.86/device2023-01: 0 reports for this device; peer average 5.71/device2023-02: 0 reports for this device; peer average 5.88/device2023-03: 0 reports for this device; peer average 8.4/device2023-04: 0 reports for this device; peer average 3/device2023-05: 0 reports for this device; peer average 5.09/device2023-06: 0 reports for this device; peer average 6.63/device2023-07: 0 reports for this device; peer average 5.18/device2023-08: 0 reports for this device; peer average 5.29/device2023-09: 0 reports for this device; peer average 6.46/device2023-10: 0 reports for this device; peer average 5.11/device2023-11: 0 reports for this device; peer average 4.85/device2023-12: 0 reports for this device; peer average 5.86/device2024-01: 0 reports for this device; peer average 5.2/device2024-02: 0 reports for this device; peer average 3.77/device2024-03: 0 reports for this device; peer average 3.28/device2024-04: 0 reports for this device; peer average 6.07/device2024-05: 0 reports for this device; peer average 2.87/device2024-06: 0 reports for this device; peer average 4/device2024-07: 0 reports for this device; peer average 2.89/device2024-08: 0 reports for this device; peer average 3.17/device2024-09: 0 reports for this device; peer average 3.93/device2024-10: 0 reports for this device; peer average 4.43/device2024-11: 0 reports for this device; peer average 2.85/device2024-12: 0 reports for this device; peer average 4.79/device2025-01: 0 reports for this device; peer average 4/device2025-02: 0 reports for this device; peer average 2.14/device2025-03: 0 reports for this device; peer average 3.37/device2025-04: 0 reports for this device; peer average 2.84/device2025-05: 0 reports for this device; peer average 5/device2025-06: 0 reports for this device; peer average 2.88/device2025-07: 0 reports for this device; peer average 4.14/device2025-08: 0 reports for this device; peer average 6.1/device2025-09: 0 reports for this device; peer average 2.48/device2025-10: 0 reports for this device; peer average 3.56/device2025-11: 0 reports for this device; peer average 5.96/device2025-12: 0 reports for this device; peer average 4.94/device2026-01: 0 reports for this device; peer average 3.4/device2026-02: 0 reports for this device; peer average 4.24/device2026-03: 0 reports for this device; peer average 5.2/device2026-04: 0 reports for this device; peer average 4.84/device2026-05: 0 reports for this device; peer average 3.96/device2026-06: 0 reports for this device; peer average 5.13/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105.38
2019-0205.13
2019-0303.47
2019-0405.67
2019-0504.9
2019-0604.6
2019-0704.26
2019-0803.77
2019-0903.47
2019-1003.38
2019-1104.86
2019-1204.13
2020-0104.92
2020-0203.07
2020-0304.94
2020-0402.54
2020-0503.07
2020-0604.33
2020-0703.28
2020-0803.36
2020-0904.41
2020-1005
2020-1105.43
2020-1205.61
2021-0103.89
2021-0204.5
2021-0305.42
2021-0404.39
2021-0504.38
2021-0603.74
2021-0704.4
2021-0806
2021-0903.3
2021-1003.22
2021-1105.09
2021-1204.04
2022-0103.37
2022-0203.21
2022-0306.82
2022-0405.6
2022-0503.58
2022-0604.58
2022-0704
2022-0805.72
2022-0904.8
2022-1004.27
2022-1106.11
2022-1204.86
2023-0105.71
2023-0205.88
2023-0308.4
2023-0403
2023-0505.09
2023-0606.63
2023-0705.18
2023-0805.29
2023-0906.46
2023-1005.11
2023-1104.85
2023-1205.86
2024-0105.2
2024-0203.77
2024-0303.28
2024-0406.07
2024-0502.87
2024-0604
2024-0702.89
2024-0803.17
2024-0903.93
2024-1004.43
2024-1102.85
2024-1204.79
2025-0104
2025-0202.14
2025-0303.37
2025-0402.84
2025-0505
2025-0602.88
2025-0704.14
2025-0806.1
2025-0902.48
2025-1003.56
2025-1105.96
2025-1204.94
2026-0103.4
2026-0204.24
2026-0305.2
2026-0404.84
2026-0503.96
2026-0605.13
This device (reports/month)Average device in HWR (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