Device product
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Z-1960-2019
Product summary
- Event
- Event 83099
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92
- Official record key
device-enforcement:Z-1960-2019
Official wording
Reason: Lack of an adequate sterilization validation.
Code information: Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083 2591050 2771027 3231028 MJ54320 MJ54330 MJ54350 MJ54340
Distribution pattern: The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.
Derived failure modes
-
Unknown
Lack of an adequate sterilization validation.