Device product
ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Z-1476-2018
Product summary
- Event
- Event 79681
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,483 total products
- Official record key
device-enforcement:Z-1476-2018
Official wording
Reason: Potential failure of sterile packaging seal.
Code information: Lot Numbers: 63645655 63650115 63650116 63655995 63655996 63655997 63655998
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.