Device product
M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Z-1474-2018
Product summary
- Event
- Event 79681
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,483 total products
- Official record key
device-enforcement:Z-1474-2018
Official wording
Reason: Potential failure of sterile packaging seal.
Code information: Lot Numbers: 63733046 63758426 77006554
Distribution pattern: US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
Derived failure modes
-
Unknown
Potential failure of sterile packaging seal.