Device product
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
Z-2533-2018
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 80401
- Status
- Terminated
- Classification
- Class II
- Quantity
- 756
- Official record key
device-enforcement:Z-2533-2018
Official wording
Reason: Products do not meet a tensile strength specification
Code information: Lot Number:MCZ162
Distribution pattern: Japan
Derived failure modes
-
Unknown
Products do not meet a tensile strength specification