Reported Jun 8, 2016 · Terminated

Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

Integra York PA, Inc.

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: Integra York PA, Inc · 589 Davies Dr · York, PA · 17402-8630

Is this the product you have?

  • Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
Lot codes and dates
    • Catalogue No. 4-405
    • Lot # 97327
Amount recalled
678 Chisel Blade Holders

Where it was sold

  • Nationwide

Why it was recalled

One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.

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 Apr 17, 2017 · Data as of Sep 19, 4:44 PM UTC

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