Device product
PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
Z-2532-2018
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 80401
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4992
- Official record key
device-enforcement:Z-2532-2018
Official wording
Reason: Products do not meet a tensile strength specification
Code information: Lot Number: MBK743
Distribution pattern: Japan
Derived failure modes
-
Unknown
Products do not meet a tensile strength specification