Device product
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Z-0137-2016
Product summary
- Event
- Event 72366
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0137-2016
Official wording
Reason: The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Code information: Lot Code # 101465 Model # 19-5000
Distribution pattern: Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
Derived failure modes
-
Unknown
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.