Device product
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
Z-1681-2016
Product summary
- Event
- Event 73981
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50
- Official record key
device-enforcement:Z-1681-2016
Official wording
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Code information: LOT: 63275969
Distribution pattern: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
Derived failure modes
-
Unknown
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.