Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Ascension MCP Joint Replacement

Model MCP-DIS-HAL · Smith & Nephew, Inc. · DI 00885556856833

HAB — Saw, Powered, And Accessories · Class I · 21 CFR 878.4820

HTT — Burr, Orthopedic · Class I · 21 CFR 888.4540

HTZ — Instrument, Cutting, Orthopedic · Class I · 21 CFR 878.4800

UDILibrary device dossier · generated 2026-09-13 · 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.

101929382019-01: 0 reports for this device; peer average 5.28/device2019-02: 0 reports for this device; peer average 5.14/device2019-03: 0 reports for this device; peer average 4.9/device2019-04: 0 reports for this device; peer average 3.45/device2019-05: 0 reports for this device; peer average 4.21/device2019-06: 0 reports for this device; peer average 4/device2019-07: 0 reports for this device; peer average 5.23/device2019-08: 0 reports for this device; peer average 5.4/device2019-09: 0 reports for this device; peer average 5.62/device2019-10: 0 reports for this device; peer average 5/device2019-11: 0 reports for this device; peer average 8.14/device2019-12: 0 reports for this device; peer average 6.78/device2020-01: 0 reports for this device; peer average 7.71/device2020-02: 0 reports for this device; peer average 7.4/device2020-03: 0 reports for this device; peer average 8.75/device2020-04: 0 reports for this device; peer average 3.67/device2020-05: 0 reports for this device; peer average 6.2/device2020-06: 0 reports for this device; peer average 16.64/device2020-07: 0 reports for this device; peer average 17.38/device2020-08: 0 reports for this device; peer average 24.18/device2020-09: 0 reports for this device; peer average 26.62/device2020-10: 0 reports for this device; peer average 30.16/device2020-11: 0 reports for this device; peer average 19.13/device2020-12: 0 reports for this device; peer average 24.94/device2021-01: 0 reports for this device; peer average 28.58/device2021-02: 0 reports for this device; peer average 37/device2021-03: 0 reports for this device; peer average 38.37/device2021-04: 0 reports for this device; peer average 33.7/device2021-05: 0 reports for this device; peer average 30.19/device2021-06: 0 reports for this device; peer average 10.95/device2021-07: 0 reports for this device; peer average 7.8/device2021-08: 0 reports for this device; peer average 6.79/device2021-09: 0 reports for this device; peer average 5.53/device2021-10: 0 reports for this device; peer average 9.07/device2021-11: 0 reports for this device; peer average 8.86/device2021-12: 0 reports for this device; peer average 8.2/device2022-01: 0 reports for this device; peer average 11.71/device2022-02: 0 reports for this device; peer average 8.4/device2022-03: 0 reports for this device; peer average 5.88/device2022-04: 0 reports for this device; peer average 5.61/device2022-05: 0 reports for this device; peer average 6.86/device2022-06: 0 reports for this device; peer average 5.76/device2022-07: 0 reports for this device; peer average 4.5/device2022-08: 0 reports for this device; peer average 5.69/device2022-09: 0 reports for this device; peer average 5.93/device2022-10: 0 reports for this device; peer average 5.65/device2022-11: 0 reports for this device; peer average 7.94/device2022-12: 0 reports for this device; peer average 7.93/device2023-01: 0 reports for this device; peer average 10.6/device2023-02: 0 reports for this device; peer average 7.15/device2023-03: 0 reports for this device; peer average 6.85/device2023-04: 0 reports for this device; peer average 4.21/device2023-05: 0 reports for this device; peer average 4.78/device2023-06: 0 reports for this device; peer average 21.29/device2023-07: 0 reports for this device; peer average 14.5/device2023-08: 0 reports for this device; peer average 12.07/device2023-09: 0 reports for this device; peer average 10.62/device2023-10: 0 reports for this device; peer average 6.55/device2023-11: 0 reports for this device; peer average 7.36/device2023-12: 0 reports for this device; peer average 5.58/device2024-01: 0 reports for this device; peer average 7.07/device2024-02: 0 reports for this device; peer average 6/device2024-03: 0 reports for this device; peer average 5.93/device2024-04: 0 reports for this device; peer average 6.3/device2024-05: 0 reports for this device; peer average 9.15/device2024-06: 0 reports for this device; peer average 5.6/device2024-07: 0 reports for this device; peer average 5.59/device2024-08: 0 reports for this device; peer average 3.96/device2024-09: 0 reports for this device; peer average 3.09/device2024-10: 0 reports for this device; peer average 3.72/device2024-11: 0 reports for this device; peer average 5.82/device2024-12: 0 reports for this device; peer average 5.25/device2025-01: 0 reports for this device; peer average 4.23/device2025-02: 0 reports for this device; peer average 4.36/device2025-03: 0 reports for this device; peer average 5.11/device2025-04: 0 reports for this device; peer average 3.3/device2025-05: 0 reports for this device; peer average 2.9/device2025-06: 0 reports for this device; peer average 3.08/device2025-07: 0 reports for this device; peer average 4.23/device2025-08: 0 reports for this device; peer average 3.5/device2025-09: 0 reports for this device; peer average 5.11/device2025-10: 0 reports for this device; peer average 7.91/device2025-11: 0 reports for this device; peer average 3.75/device2025-12: 0 reports for this device; peer average 4.3/device2026-01: 0 reports for this device; peer average 5.15/device2026-02: 0 reports for this device; peer average 9.41/device2026-03: 0 reports for this device; peer average 4.83/device2026-04: 0 reports for this device; peer average 4.18/device2026-05: 0 reports for this device; peer average 5.25/device2026-06: 0 reports for this device; peer average 5.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105.28
2019-0205.14
2019-0304.9
2019-0403.45
2019-0504.21
2019-0604
2019-0705.23
2019-0805.4
2019-0905.62
2019-1005
2019-1108.14
2019-1206.78
2020-0107.71
2020-0207.4
2020-0308.75
2020-0403.67
2020-0506.2
2020-06016.64
2020-07017.38
2020-08024.18
2020-09026.62
2020-10030.16
2020-11019.13
2020-12024.94
2021-01028.58
2021-02037
2021-03038.37
2021-04033.7
2021-05030.19
2021-06010.95
2021-0707.8
2021-0806.79
2021-0905.53
2021-1009.07
2021-1108.86
2021-1208.2
2022-01011.71
2022-0208.4
2022-0305.88
2022-0405.61
2022-0506.86
2022-0605.76
2022-0704.5
2022-0805.69
2022-0905.93
2022-1005.65
2022-1107.94
2022-1207.93
2023-01010.6
2023-0207.15
2023-0306.85
2023-0404.21
2023-0504.78
2023-06021.29
2023-07014.5
2023-08012.07
2023-09010.62
2023-1006.55
2023-1107.36
2023-1205.58
2024-0107.07
2024-0206
2024-0305.93
2024-0406.3
2024-0509.15
2024-0605.6
2024-0705.59
2024-0803.96
2024-0903.09
2024-1003.72
2024-1105.82
2024-1205.25
2025-0104.23
2025-0204.36
2025-0305.11
2025-0403.3
2025-0502.9
2025-0603.08
2025-0704.23
2025-0803.5
2025-0905.11
2025-1007.91
2025-1103.75
2025-1204.3
2026-0105.15
2026-0209.41
2026-0304.83
2026-0404.18
2026-0505.25
2026-0605.56
This device (reports/month)Average device in HAB, HTT, HTZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations