Device product
Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;
Z-0772-2021
Product summary
- Event
- Event 86927
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 units
- Official record key
device-enforcement:Z-0772-2021
Official wording
Reason: Manufacturing packaging error.
Code information: Model #: 71675535 & 71675532 Lot #: 20CM25278 & 20DM01466.
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB.
Derived failure modes
-
Labeling or packaging
packaging error
-
Manufacturing or process control
Manufacturing packaging error