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 Driver6.2mm Reamer3.2mm Reamer2 mm DrillSpade Tip Guide Wireand 1.6mm x 12 K-Wire
- Lot codes and dates
Part #ST6100Lot/Serial #'s: A251217-04A011217-01A011217-03A091017-05A101017-01A111017-01A121017-01A121017-02A131017-01A140917-01A161017-01A171017-01A181017-07A221117-01A271117-01A281117-02A291117-01A291117-03A301117-01A281117-01
- 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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