Recall Z-0442-2019— Arthrex, Inc.
Class II · Ongoing
Class II FDA medical device recall by Arthrex, Inc., initiated 2018-09-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There is potential to break during use..
- Recalling firm
- Arthrex, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-09-13
- Firm location
- Naples, FL, United States
Product 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.
Reason for recall
There is potential to break during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.