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K-Wires

Model WIRE-1.1/100 · Trimed, INC. · DI 00842188109331

NDL — Pin, Fixation, Smooth, Metallic · Class II · 21 CFR 888.3040

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 (3)

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: 3

12232021-10: 3 reports for this device; peer average 3/device10
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-1033
This device (reports/month)Average device in NDL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Trimed, INC.

  • Warning Letter 2016-06-30 TriMed Inc.
  • Warning Letter 2016-06-30 TriMed Inc.
  • VAI 2024-06-03 TriMed Inc. · 2 citations
  • VAI 2024-06-03 TriMed Inc. · 2 citations
  • NAI 2019-08-14 TriMed Inc. · 0 citations
  • NAI 2019-08-14 TriMed Inc. · 0 citations
  • VAI 2017-11-17 TriMed Inc. · 6 citations
  • VAI 2017-11-17 TriMed Inc. · 6 citations
  • VAI 2017-01-12 TriMed Inc. · 11 citations
  • VAI 2017-01-12 TriMed Inc. · 11 citations
  • OAI 2016-03-18 TriMed Inc. · 13 citations
  • OAI 2016-03-18 TriMed Inc. · 13 citations
  • VAI 2012-01-25 TriMed Inc. · 5 citations
  • VAI 2012-01-25 TriMed Inc. · 5 citations