Reported Nov 21, 2018 · Ongoing

3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail…

Arthrex, 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: Arthrex, Inc. · 1370 Creekside Blvd · Naples, FL · 34108-1945

Is this the product you have?

  • 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack
  • FibuLock Nail Procedure PackContains instrumentation for the implantation of the FibuLock implant
  • Contents include
    • Actuation Driver
    • 6.2mm Reamer
    • 3.2mm Reamer
    • 2 mm Drill
    • Spade Tip Guide Wire
    • and 1.6mm x 12 K-Wire
Lot codes and dates
    • Part #ST6100
    • Lot/Serial #'s: A251217-04
    • A011217-01
    • A011217-03
    • A091017-05
    • A101017-01
    • A111017-01
    • A121017-01
    • A121017-02
    • A131017-01
    • A140917-01
    • A161017-01
    • A171017-01
    • A181017-07
    • A221117-01
    • A271117-01
    • A281117-02
    • A291117-01
    • A291117-03
    • A301117-01
    • A281117-01
Amount recalled
832

Where it was sold

Why it was recalled

There is potential to break during use.

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

Data as of Sep 19, 5:33 PM UTC

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