Device product
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Z-0650-2022
Product summary
- Event
- Event 89482
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-0650-2022
Official wording
Reason: Incorrect marketing label (25 mm) was applied to product size 20 mm.
Code information: Model No. CP20120; Lot No. MS2117816; UDI No. (01)04048266150394(17)260706(10)MS2117816
Distribution pattern: Domestic: Illinois; Foreign: Germany.
Derived failure modes
-
Unknown
Incorrect marketing label (25 mm) was applied to product size 20 mm.