Device product
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
Z-1678-2016
Product summary
- Event
- Event 73981
- Status
- Terminated
- Classification
- Class II
- Quantity
- 219
- Official record key
device-enforcement:Z-1678-2016
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: LOTS: 63295051 63293672
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.