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ACUFEX

Model 72201249 · Smith & Nephew, Inc. · DI 03596010585325

NBH — Accessories, Arthroscopic · Class I · 21 CFR 888.1100

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.

13462019-01: 0 reports for this device; peer average 2.33/device2019-02: 0 reports for this device; peer average 1.53/device2019-03: 0 reports for this device; peer average 2.33/device2019-04: 0 reports for this device; peer average 2.14/device2019-05: 0 reports for this device; peer average 2.28/device2019-06: 0 reports for this device; peer average 2.4/device2019-07: 0 reports for this device; peer average 1.92/device2019-08: 0 reports for this device; peer average 2.5/device2019-09: 0 reports for this device; peer average 3.42/device2019-10: 0 reports for this device; peer average 2.26/device2019-11: 0 reports for this device; peer average 1.86/device2019-12: 0 reports for this device; peer average 2.2/device2020-01: 0 reports for this device; peer average 3.07/device2020-02: 0 reports for this device; peer average 2.29/device2020-03: 0 reports for this device; peer average 2.4/device2020-04: 0 reports for this device; peer average 1.75/device2020-05: 0 reports for this device; peer average 1.67/device2020-06: 0 reports for this device; peer average 2.95/device2020-07: 0 reports for this device; peer average 2.33/device2020-08: 0 reports for this device; peer average 2.7/device2020-09: 0 reports for this device; peer average 2.59/device2020-10: 0 reports for this device; peer average 2.84/device2020-11: 0 reports for this device; peer average 2.83/device2020-12: 0 reports for this device; peer average 2.62/device2021-01: 0 reports for this device; peer average 3.19/device2021-02: 0 reports for this device; peer average 2.67/device2021-03: 0 reports for this device; peer average 2.87/device2021-04: 0 reports for this device; peer average 3.2/device2021-05: 0 reports for this device; peer average 2.67/device2021-06: 0 reports for this device; peer average 2.46/device2021-07: 0 reports for this device; peer average 2.4/device2021-08: 0 reports for this device; peer average 2.05/device2021-09: 0 reports for this device; peer average 2.9/device2021-10: 0 reports for this device; peer average 2.62/device2021-11: 0 reports for this device; peer average 2.63/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2.63/device2022-02: 0 reports for this device; peer average 1.65/device2022-03: 0 reports for this device; peer average 2.41/device2022-04: 0 reports for this device; peer average 2.59/device2022-05: 0 reports for this device; peer average 2.73/device2022-06: 0 reports for this device; peer average 1.89/device2022-07: 0 reports for this device; peer average 2.29/device2022-08: 0 reports for this device; peer average 2.4/device2022-09: 0 reports for this device; peer average 2.17/device2022-10: 0 reports for this device; peer average 2.47/device2022-11: 0 reports for this device; peer average 2.32/device2022-12: 0 reports for this device; peer average 3.59/device2023-01: 0 reports for this device; peer average 2.25/device2023-02: 0 reports for this device; peer average 3.1/device2023-03: 0 reports for this device; peer average 2.81/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 4.46/device2023-06: 0 reports for this device; peer average 3.52/device2023-07: 0 reports for this device; peer average 3.38/device2023-08: 0 reports for this device; peer average 2.3/device2023-09: 0 reports for this device; peer average 3.46/device2023-10: 0 reports for this device; peer average 2.64/device2023-11: 0 reports for this device; peer average 3.76/device2023-12: 0 reports for this device; peer average 3.56/device2024-01: 0 reports for this device; peer average 2.48/device2024-02: 0 reports for this device; peer average 2.73/device2024-03: 0 reports for this device; peer average 2.95/device2024-04: 0 reports for this device; peer average 2.32/device2024-05: 0 reports for this device; peer average 4.15/device2024-06: 0 reports for this device; peer average 5.53/device2024-07: 0 reports for this device; peer average 3.14/device2024-08: 0 reports for this device; peer average 2.3/device2024-09: 0 reports for this device; peer average 2.76/device2024-10: 0 reports for this device; peer average 2.61/device2024-11: 0 reports for this device; peer average 2.5/device2024-12: 0 reports for this device; peer average 2.7/device2025-01: 0 reports for this device; peer average 3.35/device2025-02: 0 reports for this device; peer average 3.62/device2025-03: 0 reports for this device; peer average 3.11/device2025-04: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 2.44/device2025-07: 0 reports for this device; peer average 2.88/device2025-08: 0 reports for this device; peer average 2.84/device2025-09: 0 reports for this device; peer average 1.89/device2025-10: 0 reports for this device; peer average 3/device2025-11: 0 reports for this device; peer average 2.94/device2025-12: 0 reports for this device; peer average 3.71/device2026-01: 0 reports for this device; peer average 2.45/device2026-02: 0 reports for this device; peer average 3.21/device2026-03: 0 reports for this device; peer average 2.39/device2026-04: 0 reports for this device; peer average 2.57/device2026-05: 0 reports for this device; peer average 3.8/device2026-06: 0 reports for this device; peer average 2.86/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.33
2019-0201.53
2019-0302.33
2019-0402.14
2019-0502.28
2019-0602.4
2019-0701.92
2019-0802.5
2019-0903.42
2019-1002.26
2019-1101.86
2019-1202.2
2020-0103.07
2020-0202.29
2020-0302.4
2020-0401.75
2020-0501.67
2020-0602.95
2020-0702.33
2020-0802.7
2020-0902.59
2020-1002.84
2020-1102.83
2020-1202.62
2021-0103.19
2021-0202.67
2021-0302.87
2021-0403.2
2021-0502.67
2021-0602.46
2021-0702.4
2021-0802.05
2021-0902.9
2021-1002.62
2021-1102.63
2021-1202
2022-0102.63
2022-0201.65
2022-0302.41
2022-0402.59
2022-0502.73
2022-0601.89
2022-0702.29
2022-0802.4
2022-0902.17
2022-1002.47
2022-1102.32
2022-1203.59
2023-0102.25
2023-0203.1
2023-0302.81
2023-0402
2023-0504.46
2023-0603.52
2023-0703.38
2023-0802.3
2023-0903.46
2023-1002.64
2023-1103.76
2023-1203.56
2024-0102.48
2024-0202.73
2024-0302.95
2024-0402.32
2024-0504.15
2024-0605.53
2024-0703.14
2024-0802.3
2024-0902.76
2024-1002.61
2024-1102.5
2024-1202.7
2025-0103.35
2025-0203.62
2025-0303.11
2025-0403
2025-0503
2025-0602.44
2025-0702.88
2025-0802.84
2025-0901.89
2025-1003
2025-1102.94
2025-1203.71
2026-0102.45
2026-0203.21
2026-0302.39
2026-0402.57
2026-0503.8
2026-0602.86
This device (reports/month)Average device in NBH (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