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1.5MM SYSTEM

Model 01-7430 · BIOMET MICROFIXATION, INC · DI 00841036284220

LRP — Tray, Surgical · Class I · 21 CFR 878.4800

UDILibrary device dossier · generated 2026-09-15 · 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.

23562019-05: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 6/device2025-03: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device051112091009030710020706080903050711030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0501
2019-1102
2019-1201
2020-0901
2020-1002
2021-0902
2022-0302
2022-0703
2022-1002
2023-0203
2023-0701.5
2024-0601
2024-0803
2024-0906
2025-0302
2025-0501
2025-0701
2025-1102
2026-0302
2026-0502
2026-0602
This device (reports/month)Average device in LRP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BIOMET MICROFIXATION, INC

  • VAI 2025-03-04 Zimmer Biomet CMF and Thoracic LLC · 3 citations
  • VAI 2018-05-24 Zimmer Biomet CMF and Thoracic LLC · 1 citations
  • VAI 2017-09-01 Zimmer Biomet CMF and Thoracic LLC · 3 citations
  • VAI 2015-10-30 Zimmer Biomet CMF and Thoracic LLC · 1 citations
  • VAI 2012-01-17 Zimmer Biomet CMF and Thoracic LLC · 2 citations