Device product
ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Z-1470-2018
Product summary
- Event
- Event 79681
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19483 total products
- Official record key
device-enforcement:Z-1470-2018
Official wording
Reason: Potential failure of sterile packaging seal.
Code information: Lot Numbers: 63662549 63668704 63696974 63709171 63721377 63731176 63764550 63771164 63781920 63803595 63812302 63817719 63826242
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.