Device product
Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
Z-1841-2016
Product summary
- Event
- Event 74079
- Status
- Terminated
- Classification
- Class II
- Quantity
- 678 Chisel Blade Holders
- Official record key
device-enforcement:Z-1841-2016
Official wording
Reason: One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
Code information: Catalogue No. 4-405, Lot # 97327
Distribution pattern: Worldwide distribution. US nationwide, Mexico, and Korea.
Derived failure modes
-
Unknown
One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.