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

ACUFEX

Model 72204044 · Smith & Nephew, Inc. · DI 00885554037739

GFG — Bit, Surgical · Class I · 21 CFR 878.4820

UDILibrary device dossier · generated 2026-09-11 · 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 (66)

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.

Malfunction: 38 · Injury: 28

4913172019-02: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1.33/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1.4/device2020-04: 1 reports for this device; peer average 1.4/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 6 reports for this device; peer average 4.5/device2020-08: 3 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 4.5/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 2/device2021-01: 6 reports for this device; peer average 3.14/device2021-03: 0 reports for this device; peer average 2.75/device2021-04: 0 reports for this device; peer average 1.33/device2021-05: 0 reports for this device; peer average 3.14/device2021-06: 6 reports for this device; peer average 3.67/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 3.25/device2021-09: 3 reports for this device; peer average 1.8/device2021-10: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 4.5/device2021-12: 0 reports for this device; peer average 3/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 2.5/device2022-03: 0 reports for this device; peer average 2.75/device2022-04: 0 reports for this device; peer average 1/device2022-05: 3 reports for this device; peer average 2.33/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 2.17/device2022-08: 0 reports for this device; peer average 2.29/device2022-09: 3 reports for this device; peer average 2.86/device2022-10: 6 reports for this device; peer average 3.25/device2022-11: 0 reports for this device; peer average 2.5/device2022-12: 0 reports for this device; peer average 3.4/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1.5/device2023-05: 6 reports for this device; peer average 2.5/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1.5/device2023-08: 2 reports for this device; peer average 2.2/device2023-09: 2 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.67/device2023-11: 0 reports for this device; peer average 1.67/device2023-12: 0 reports for this device; peer average 2.33/device2024-01: 0 reports for this device; peer average 1.33/device2024-02: 0 reports for this device; peer average 1.67/device2024-03: 0 reports for this device; peer average 3.25/device2024-04: 0 reports for this device; peer average 3/device2024-05: 0 reports for this device; peer average 2/device2024-06: 2 reports for this device; peer average 2.25/device2024-08: 0 reports for this device; peer average 1.6/device2024-09: 0 reports for this device; peer average 1.75/device2024-10: 0 reports for this device; peer average 2.33/device2024-11: 2 reports for this device; peer average 5.67/device2024-12: 1 reports for this device; peer average 8.67/device2025-01: 2 reports for this device; peer average 2.6/device2025-02: 0 reports for this device; peer average 7/device2025-03: 0 reports for this device; peer average 5.33/device2025-04: 0 reports for this device; peer average 4.25/device2025-05: 0 reports for this device; peer average 3.33/device2025-06: 0 reports for this device; peer average 5/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 1.83/device2025-09: 0 reports for this device; peer average 3.17/device2025-10: 2 reports for this device; peer average 2.44/device2025-11: 2 reports for this device; peer average 3.8/device2025-12: 0 reports for this device; peer average 4.33/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 6 reports for this device; peer average 3.8/device2026-03: 0 reports for this device; peer average 2.8/device2026-04: 0 reports for this device; peer average 4/device2026-05: 0 reports for this device; peer average 17/device2026-06: 2 reports for this device; peer average 2/device020405060708091012010203040506070809101112010304050607080910111201020304050607080910111201020305060708091011120102030405060809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0401
2019-0501
2019-0601.33
2019-0701
2019-0801
2019-0901.5
2019-1001
2019-1201.5
2020-0101
2020-0201
2020-0301.4
2020-0411.4
2020-0501
2020-0601
2020-0764.5
2020-0832
2020-0903
2020-1004.5
2020-1101
2020-1202
2021-0163.14
2021-0302.75
2021-0401.33
2021-0503.14
2021-0663.67
2021-0702
2021-0803.25
2021-0931.8
2021-1004
2021-1104.5
2021-1203
2022-0101
2022-0202.5
2022-0302.75
2022-0401
2022-0532.33
2022-0602.5
2022-0702.17
2022-0802.29
2022-0932.86
2022-1063.25
2022-1102.5
2022-1203.4
2023-0102
2023-0202
2023-0301.5
2023-0562.5
2023-0601
2023-0701.5
2023-0822.2
2023-0922
2023-1001.67
2023-1101.67
2023-1202.33
2024-0101.33
2024-0201.67
2024-0303.25
2024-0403
2024-0502
2024-0622.25
2024-0801.6
2024-0901.75
2024-1002.33
2024-1125.67
2024-1218.67
2025-0122.6
2025-0207
2025-0305.33
2025-0404.25
2025-0503.33
2025-0605
2025-0702
2025-0801.83
2025-0903.17
2025-1022.44
2025-1123.8
2025-1204.33
2026-0101.5
2026-0263.8
2026-0302.8
2026-0404
2026-05017
2026-0622
This device (reports/month)Average device in GFG (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