Recall Z-0442-2019 ยท HTO Reamer
Arthrex, Inc.
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.
| Date | Sep 13, 2018 |
| Status | Open, Classified |
| Reason | There is potential to break during use. |
| Root cause | Software change control |
| Action | 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 complaints@arthrex.com 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 |
| Quantity | 832 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.