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.
Recall
- Recall Number
- Z-0442-2019
- Event Number
- 81119
- Firm
- Arthrex, Inc.
- FEI Number
- 1220246
- Product Code
- HTO
- Status
- Open, Classified
- Root Cause
- Software change control
- Initiated
- September 13, 2018
- Address
- 1370 Creekside Blvd, Naples, FL, 34108-1945
Description
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.
There is potential to break during use.
Arthrex sent letters to their consignees with the following instructions. 1. Immediately discontinue use, sale, and distribution of the affected product. 2. Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected] as soon as possible to arrange for return of the affected product. Our Product Surveillance Specialists can provide assistance regarding alternative solutions and are available to answer questions regarding credit for affected devices in your possession. 3. If you are an Arthrex agency, you do not need to notify any customers as Arthrex will be notifying customers directly. 4. If you are an Arthrex customer, you do not need to notify any patients of this product recall. 5. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or [email protected].
Distributed throughout the U.S. to the following states: NC, CA, NJ, CO, NV, UT, LA, KY, OH, AZ, MO, MN, TN, NY, WI, MA, PA, TX, IL, PA, AR, FL, IA, MI, AL, SD, OR, WA, MD, KS, and GA.
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