Device product
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Z-0474-2014
Product summary
- Event
- Event 66409
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-0474-2014
Official wording
Reason: Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
Code information: Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.
Distribution pattern: Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
Derived failure modes
-
Labeling or packaging
incorrect labeling