Device product
PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
Z-2534-2018
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 80401
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72
- Official record key
device-enforcement:Z-2534-2018
Official wording
Reason: Products do not meet a tensile strength specification
Code information: Lot Number: MCZ363
Distribution pattern: Japan
Derived failure modes
-
Unknown
Products do not meet a tensile strength specification