Device product
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
Z-0549-2018
Product summary
- Event
- Event 78219
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,888 units
- Official record key
device-enforcement:Z-0549-2018
Official wording
Reason: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.
Code information: All Lot Numbers Expiry Date Before April 2022
Distribution pattern: Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
Derived failure modes
-
Unknown
The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.