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Angled Nozzle

Model 4149 · BIOMET · DI 07350023771429

KIH — Dispenser, Cement · Class I · 21 CFR 888.4200

UDILibrary device dossier · generated 2026-09-14 · 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.

91827362019-01: 0 reports for this device; peer average 2.25/device2019-02: 0 reports for this device; peer average 8/device2019-03: 0 reports for this device; peer average 1.5/device2019-04: 0 reports for this device; peer average 4.83/device2019-05: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 8.5/device2019-07: 0 reports for this device; peer average 3.2/device2019-08: 0 reports for this device; peer average 19.5/device2019-09: 0 reports for this device; peer average 16.67/device2019-10: 0 reports for this device; peer average 20.25/device2019-11: 0 reports for this device; peer average 36/device2019-12: 0 reports for this device; peer average 26.5/device2020-01: 0 reports for this device; peer average 17.75/device2020-02: 0 reports for this device; peer average 5.5/device2020-03: 0 reports for this device; peer average 14.5/device2020-04: 0 reports for this device; peer average 5/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 8.33/device2020-07: 0 reports for this device; peer average 2.86/device2020-08: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 4/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 14/device2020-12: 0 reports for this device; peer average 7.5/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 14/device2021-03: 0 reports for this device; peer average 13/device2021-04: 0 reports for this device; peer average 10.25/device2021-05: 0 reports for this device; peer average 18/device2021-06: 0 reports for this device; peer average 3.5/device2021-07: 0 reports for this device; peer average 7.67/device2021-08: 0 reports for this device; peer average 10/device2021-09: 0 reports for this device; peer average 3.33/device2021-10: 0 reports for this device; peer average 1.67/device2021-11: 0 reports for this device; peer average 2.2/device2021-12: 0 reports for this device; peer average 4.5/device2022-01: 0 reports for this device; peer average 1.33/device2022-02: 0 reports for this device; peer average 1.5/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 1.67/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 4.33/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 2.8/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 1.25/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1.14/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2.25/device2023-07: 0 reports for this device; peer average 1.33/device2023-08: 0 reports for this device; peer average 1.67/device2023-09: 0 reports for this device; peer average 2.67/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 4.5/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2.67/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1.5/device2024-09: 0 reports for this device; peer average 2.5/device2024-10: 0 reports for this device; peer average 1.25/device2024-11: 0 reports for this device; peer average 4/device2024-12: 0 reports for this device; peer average 8/device2025-01: 0 reports for this device; peer average 1.4/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2.67/device2025-04: 0 reports for this device; peer average 1.67/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 2.89/device2025-07: 0 reports for this device; peer average 1.67/device2025-08: 0 reports for this device; peer average 8.5/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 3.83/device2025-11: 0 reports for this device; peer average 10.5/device2025-12: 0 reports for this device; peer average 3.5/device2026-01: 0 reports for this device; peer average 1.33/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 1.33/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device0102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.25
2019-0208
2019-0301.5
2019-0404.83
2019-0503
2019-0608.5
2019-0703.2
2019-08019.5
2019-09016.67
2019-10020.25
2019-11036
2019-12026.5
2020-01017.75
2020-0205.5
2020-03014.5
2020-0405
2020-0502
2020-0608.33
2020-0702.86
2020-0803
2020-0904
2020-1002
2020-11014
2020-1207.5
2021-0103
2021-02014
2021-03013
2021-04010.25
2021-05018
2021-0603.5
2021-0707.67
2021-08010
2021-0903.33
2021-1001.67
2021-1102.2
2021-1204.5
2022-0101.33
2022-0201.5
2022-0301.5
2022-0401.67
2022-0502
2022-0603
2022-0704.33
2022-0801.5
2022-0901
2022-1002.8
2022-1101
2022-1202
2023-0101.25
2023-0202
2023-0302
2023-0401.14
2023-0502
2023-0602.25
2023-0701.33
2023-0801.67
2023-0902.67
2023-1001
2023-1104.5
2023-1201
2024-0101
2024-0202
2024-0302.67
2024-0401
2024-0501.5
2024-0701
2024-0801.5
2024-0902.5
2024-1001.25
2024-1104
2024-1208
2025-0101.4
2025-0201
2025-0302.67
2025-0401.67
2025-0503
2025-0602.89
2025-0701.67
2025-0808.5
2025-0902
2025-1003.83
2025-11010.5
2025-1203.5
2026-0101.33
2026-0202
2026-0303
2026-0401.33
2026-0501
2026-0601
This device (reports/month)Average device in KIH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BIOMET

  • Warning Letter 2018-08-24 Biomet, Inc.
  • Warning Letter 2018-08-24 Biomet, Inc.
  • Warning Letter 2015-06-03 Zhejiang Biomet Medical Products Co. Ltd.
  • Warning Letter 2010-07-27 Biomet, Inc.
  • Warning Letter 2010-07-27 Biomet, Inc.
  • VAI 2023-11-09 Biomet, Inc. · 0 citations
  • VAI 2023-11-09 Biomet, Inc. · 0 citations
  • VAI 2020-01-30 Biomet, Inc. · 8 citations
  • VAI 2020-01-30 Biomet, Inc. · 8 citations
  • OAI 2018-04-24 Biomet, Inc. · 11 citations
  • OAI 2018-04-24 Biomet, Inc. · 11 citations
  • NAI 2017-08-17 Zhejiang Biomet Medical Products Co. Ltd. · 0 citations
  • VAI 2017-08-03 Biomet UK Ltd. · 4 citations
  • NAI 2017-02-10 Biomet · 0 citations
  • NAI 2017-02-03 Biomet France SARL · 0 citations
  • OAI 2016-11-22 Biomet, Inc. · 14 citations
  • OAI 2016-11-22 Biomet, Inc. · 14 citations
  • NAI 2016-03-24 CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. · 0 citations
  • VAI 2015-03-18 Biomet UK Ltd. · 2 citations
  • OAI 2015-01-22 Zhejiang Biomet Medical Products Co. Ltd. · 0 citations
  • VAI 2014-06-30 Biomet, Inc. · 2 citations
  • VAI 2014-06-30 Biomet, Inc. · 2 citations
  • NAI 2013-01-18 Biomet · 0 citations
  • NAI 2010-03-26 Biomet, Inc. · 0 citations
  • NAI 2010-03-26 Biomet, Inc. · 0 citations