Device product
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Z-0452-2014
Product summary
- Event
- Event 66417
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17
- Official record key
device-enforcement:Z-0452-2014
Official wording
Reason: Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
Code information: Part # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.
Distribution pattern: Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
Derived failure modes
-
Unknown
Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.