Wire, Surgical
FDA adverse event reports and recall history for wire, surgical (product code LRN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,190
- Deaths
- 2
- Injuries
- 418
- Malfunctions
- 752
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- TerminatedUnder Investigation by firm
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
Potential for the wire to fracture at the threads and remain in the glenoid.
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