medical MODERATE Updated 2018-11-21

Arthrex, Inc. recalls 3.2mm Proximal Reamer/Cannulated Drill provided as part of t

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Recalled Product

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

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Hazard / Issue

There is potential to break during use.

Issued by

FDA

Affected States: NC, CA, NJ, CO, NV, UT, LA, KY, OH, AZ, MO, MN, TN, NY, WI, MA, PA, TX, IL, AR, FL, IA, MI, AL, SD, OR, WA, MD, KS, GA
Lot/Code Info: 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.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall