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ACUFEX Meniscal Root Repair

Model 71935070 · Smith & Nephew, Inc. · DI 00885556533291

GAT — Suture, Nonabsorbable, Synthetic, Polyethylene · Class II · 21 CFR 878.5000

LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540

MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030

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

UDILibrary device dossier · generated 2026-09-12 · 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 (2)

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.

Injury: 2

3610132019-01: 0 reports for this device; peer average 3.57/device2019-02: 0 reports for this device; peer average 2.59/device2019-03: 0 reports for this device; peer average 2.8/device2019-04: 0 reports for this device; peer average 2.58/device2019-05: 0 reports for this device; peer average 2.7/device2019-06: 0 reports for this device; peer average 2.57/device2019-07: 0 reports for this device; peer average 2.85/device2019-08: 0 reports for this device; peer average 2.82/device2019-09: 0 reports for this device; peer average 3.32/device2019-10: 0 reports for this device; peer average 2.62/device2019-11: 0 reports for this device; peer average 2.96/device2019-12: 0 reports for this device; peer average 3.15/device2020-01: 0 reports for this device; peer average 3.35/device2020-02: 0 reports for this device; peer average 2.45/device2020-03: 0 reports for this device; peer average 2.97/device2020-04: 0 reports for this device; peer average 3.61/device2020-05: 0 reports for this device; peer average 2.83/device2020-06: 0 reports for this device; peer average 3.12/device2020-07: 0 reports for this device; peer average 3.8/device2020-08: 0 reports for this device; peer average 3.75/device2020-09: 0 reports for this device; peer average 3.61/device2020-10: 0 reports for this device; peer average 4.35/device2020-11: 0 reports for this device; peer average 4.29/device2020-12: 0 reports for this device; peer average 4.16/device2021-01: 0 reports for this device; peer average 4.55/device2021-02: 0 reports for this device; peer average 4.14/device2021-03: 0 reports for this device; peer average 3.81/device2021-04: 0 reports for this device; peer average 4.45/device2021-05: 0 reports for this device; peer average 3.67/device2021-06: 0 reports for this device; peer average 3.44/device2021-07: 0 reports for this device; peer average 3.43/device2021-08: 0 reports for this device; peer average 3.69/device2021-09: 0 reports for this device; peer average 3.67/device2021-10: 0 reports for this device; peer average 3.54/device2021-11: 0 reports for this device; peer average 4.01/device2021-12: 0 reports for this device; peer average 3.45/device2022-01: 0 reports for this device; peer average 3.57/device2022-02: 0 reports for this device; peer average 3.78/device2022-03: 0 reports for this device; peer average 3.76/device2022-04: 0 reports for this device; peer average 3.79/device2022-05: 0 reports for this device; peer average 4.23/device2022-06: 0 reports for this device; peer average 3.1/device2022-07: 0 reports for this device; peer average 3.17/device2022-08: 0 reports for this device; peer average 3.74/device2022-09: 0 reports for this device; peer average 3.44/device2022-10: 0 reports for this device; peer average 3.96/device2022-11: 0 reports for this device; peer average 4.78/device2022-12: 0 reports for this device; peer average 4.69/device2023-01: 0 reports for this device; peer average 5.49/device2023-02: 0 reports for this device; peer average 4.75/device2023-03: 0 reports for this device; peer average 5.3/device2023-04: 0 reports for this device; peer average 5.17/device2023-05: 0 reports for this device; peer average 5.29/device2023-06: 0 reports for this device; peer average 5.69/device2023-07: 0 reports for this device; peer average 5.51/device2023-08: 0 reports for this device; peer average 5.71/device2023-09: 0 reports for this device; peer average 4.49/device2023-10: 0 reports for this device; peer average 5.04/device2023-11: 0 reports for this device; peer average 4.23/device2023-12: 0 reports for this device; peer average 5.34/device2024-01: 0 reports for this device; peer average 4.28/device2024-02: 0 reports for this device; peer average 5.42/device2024-03: 0 reports for this device; peer average 7.85/device2024-04: 0 reports for this device; peer average 12.78/device2024-05: 0 reports for this device; peer average 11.81/device2024-06: 0 reports for this device; peer average 12.03/device2024-07: 0 reports for this device; peer average 12.19/device2024-08: 0 reports for this device; peer average 7.27/device2024-09: 0 reports for this device; peer average 6.69/device2024-10: 0 reports for this device; peer average 5.11/device2024-11: 0 reports for this device; peer average 4.95/device2024-12: 0 reports for this device; peer average 4.23/device2025-01: 0 reports for this device; peer average 4.12/device2025-02: 0 reports for this device; peer average 4.49/device2025-03: 0 reports for this device; peer average 5.09/device2025-04: 0 reports for this device; peer average 3.98/device2025-05: 0 reports for this device; peer average 4.18/device2025-06: 0 reports for this device; peer average 4.26/device2025-07: 0 reports for this device; peer average 3.77/device2025-08: 0 reports for this device; peer average 3.7/device2025-09: 0 reports for this device; peer average 3.49/device2025-10: 2 reports for this device; peer average 3.59/device2025-11: 0 reports for this device; peer average 4.62/device2025-12: 0 reports for this device; peer average 4.9/device2026-01: 0 reports for this device; peer average 4.6/device2026-02: 0 reports for this device; peer average 5.29/device2026-03: 0 reports for this device; peer average 4.45/device2026-04: 0 reports for this device; peer average 4.4/device2026-05: 0 reports for this device; peer average 4.89/device2026-06: 0 reports for this device; peer average 5.1/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.57
2019-0202.59
2019-0302.8
2019-0402.58
2019-0502.7
2019-0602.57
2019-0702.85
2019-0802.82
2019-0903.32
2019-1002.62
2019-1102.96
2019-1203.15
2020-0103.35
2020-0202.45
2020-0302.97
2020-0403.61
2020-0502.83
2020-0603.12
2020-0703.8
2020-0803.75
2020-0903.61
2020-1004.35
2020-1104.29
2020-1204.16
2021-0104.55
2021-0204.14
2021-0303.81
2021-0404.45
2021-0503.67
2021-0603.44
2021-0703.43
2021-0803.69
2021-0903.67
2021-1003.54
2021-1104.01
2021-1203.45
2022-0103.57
2022-0203.78
2022-0303.76
2022-0403.79
2022-0504.23
2022-0603.1
2022-0703.17
2022-0803.74
2022-0903.44
2022-1003.96
2022-1104.78
2022-1204.69
2023-0105.49
2023-0204.75
2023-0305.3
2023-0405.17
2023-0505.29
2023-0605.69
2023-0705.51
2023-0805.71
2023-0904.49
2023-1005.04
2023-1104.23
2023-1205.34
2024-0104.28
2024-0205.42
2024-0307.85
2024-04012.78
2024-05011.81
2024-06012.03
2024-07012.19
2024-0807.27
2024-0906.69
2024-1005.11
2024-1104.95
2024-1204.23
2025-0104.12
2025-0204.49
2025-0305.09
2025-0403.98
2025-0504.18
2025-0604.26
2025-0703.77
2025-0803.7
2025-0903.49
2025-1023.59
2025-1104.62
2025-1204.9
2026-0104.6
2026-0205.29
2026-0304.45
2026-0404.4
2026-0504.89
2026-0605.1
This device (reports/month)Average device in GAT, LXH, MAI, 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