Device product
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Z-0640-2017
Product summary
- Event
- Event 75502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 319 units
- Official record key
device-enforcement:Z-0640-2017
Official wording
Reason: The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Code information: Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756
Distribution pattern: Distributed Nationwide
Derived failure modes
-
Unknown
The peel pouches for the affected reaming rods and extraction hooks are delaminating.