Device product
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Z-0641-2017
Product summary
- Event
- Event 75502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 139 units
- Official record key
device-enforcement:Z-0641-2017
Official wording
Reason: The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information: Catalog ID 355.042S, Lot Numbers: H085634; H094463.
Distribution pattern: Distributed Nationwide
Derived failure modes
-
Unknown
The peel pouches for the affected reaming rods and extraction hooks are delaminating.