Device product
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Z-1383-2022
Product summary
- Event
- Event 90483
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 pieces
- Official record key
device-enforcement:Z-1383-2022
Official wording
Reason: Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Code information: UDI-DI (GTIN): 04046955063277
Distribution pattern: United States: TX and AK
Derived failure modes
-
Labeling or packaging
incorrectly labeled