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

ARROW

Model IPN034176 · TELEFLEX INCORPORATED · DI 20801902053279

JDC — Prosthesis, Elbow, Constrained, Cemented · Class II · 21 CFR 888.3150

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.

12342019-01: 0 reports for this device; peer average 1/device2019-03: 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/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1.22/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.25/device2020-02: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1.5/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2.5/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 1.13/device2020-12: 0 reports for this device; peer average 1.5/device2021-01: 0 reports for this device; peer average 1.67/device2021-02: 0 reports for this device; peer average 1.17/device2021-03: 0 reports for this device; peer average 1.17/device2021-04: 0 reports for this device; peer average 1.14/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 1.78/device2021-07: 0 reports for this device; peer average 1.29/device2021-08: 0 reports for this device; peer average 1.86/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1.75/device2021-11: 0 reports for this device; peer average 1.38/device2021-12: 0 reports for this device; peer average 2.17/device2022-01: 0 reports for this device; peer average 1.57/device2022-02: 0 reports for this device; peer average 1.43/device2022-03: 0 reports for this device; peer average 1.8/device2022-04: 0 reports for this device; peer average 1.63/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1.29/device2022-07: 0 reports for this device; peer average 1.43/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2.09/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2.4/device2023-02: 0 reports for this device; peer average 1.4/device2023-03: 0 reports for this device; peer average 1.91/device2023-04: 0 reports for this device; peer average 1.6/device2023-05: 0 reports for this device; peer average 1.58/device2023-06: 0 reports for this device; peer average 1.57/device2023-07: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 1.4/device2023-09: 0 reports for this device; peer average 1.13/device2023-10: 0 reports for this device; peer average 1.64/device2023-11: 0 reports for this device; peer average 1.27/device2023-12: 0 reports for this device; peer average 1.08/device2024-01: 0 reports for this device; peer average 1.92/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.5/device2024-04: 0 reports for this device; peer average 1.31/device2024-05: 0 reports for this device; peer average 1.17/device2024-06: 0 reports for this device; peer average 2.15/device2024-07: 0 reports for this device; peer average 1.29/device2024-08: 0 reports for this device; peer average 1.8/device2024-09: 0 reports for this device; peer average 3.75/device2024-10: 0 reports for this device; peer average 1.41/device2024-11: 0 reports for this device; peer average 1.47/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.15/device2025-02: 0 reports for this device; peer average 1.22/device2025-03: 0 reports for this device; peer average 1.11/device2025-04: 0 reports for this device; peer average 1.3/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1.15/device2025-07: 0 reports for this device; peer average 1.15/device2025-08: 0 reports for this device; peer average 1.38/device2025-09: 0 reports for this device; peer average 1.17/device2025-10: 0 reports for this device; peer average 1.8/device2025-11: 0 reports for this device; peer average 1.79/device2025-12: 0 reports for this device; peer average 1.65/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1.21/device2026-04: 0 reports for this device; peer average 1.47/device2026-05: 0 reports for this device; peer average 1.33/device2026-06: 0 reports for this device; peer average 1/device01030405061011120102040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0301
2019-0401
2019-0501
2019-0601
2019-1001
2019-1101.22
2019-1201
2020-0101.25
2020-0202
2020-0401
2020-0501
2020-0601.5
2020-0701
2020-0801
2020-0902.5
2020-1002
2020-1101.13
2020-1201.5
2021-0101.67
2021-0201.17
2021-0301.17
2021-0401.14
2021-0503
2021-0601.78
2021-0701.29
2021-0801.86
2021-0902
2021-1001.75
2021-1101.38
2021-1202.17
2022-0101.57
2022-0201.43
2022-0301.8
2022-0401.63
2022-0502
2022-0601.29
2022-0701.43
2022-0802
2022-0902
2022-1002
2022-1102.09
2022-1202
2023-0102.4
2023-0201.4
2023-0301.91
2023-0401.6
2023-0501.58
2023-0601.57
2023-0701.5
2023-0801.4
2023-0901.13
2023-1001.64
2023-1101.27
2023-1201.08
2024-0101.92
2024-0201
2024-0301.5
2024-0401.31
2024-0501.17
2024-0602.15
2024-0701.29
2024-0801.8
2024-0903.75
2024-1001.41
2024-1101.47
2024-1201
2025-0101.15
2025-0201.22
2025-0301.11
2025-0401.3
2025-0501
2025-0601.15
2025-0701.15
2025-0801.38
2025-0901.17
2025-1001.8
2025-1101.79
2025-1201.65
2026-0101
2026-0201
2026-0301.21
2026-0401.47
2026-0501.33
2026-0601
This device (reports/month)Average device in JDC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — TELEFLEX INCORPORATED

  • NAI 2026-01-15 Teleflex Medical OEM LLC · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-01-26 Teleflex Medical OEM LLC · 0 citations
  • NAI 2022-12-09 Teleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company) · 0 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • VAI 2021-07-30 Teleflex LLC (NADC) · 4 citations
  • NAI 2017-09-21 Teleflex LLC · 0 citations
  • VAI 2017-09-20 Teleflex Medical, Inc. · 1 citations
  • NAI 2017-02-02 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-08-29 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2015-08-13 Teleflex Medical Sdn. Bhd. · 0 citations
  • NAI 2015-06-05 Teleflex Medical Europe Ltd · 0 citations
  • NAI 2015-02-25 Teleflex Medical Europe, Ltd. · 0 citations
  • NAI 2014-08-28 TELEFLEX LLC · 0 citations