Reported Jul 15, 2020 · Terminated

Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

XTANT Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: XTANT Medical · 664 Cruiser Ln · Belgrade, MT · 59714-9719

Is this the product you have?

  • Irix-C Forceps Inserter
  • Product Code/UDIT066-0059/ M697T06600591
Lot codes and dates
  • LOTXS1920458A
Amount recalled
4 units

Where it was sold

Why it was recalled

The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 19, 2021 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.