FDA recall Z-2534-2018
Ethicon, Inc. · Class II · 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)
Reason for recall
Products do not meet a tensile strength specification
Distribution
Japan
Key facts
- Status
- Terminated
- Initiation date
- 2018-06-08
- Report date
- 2018-08-01
- Termination date
- 2020-09-25
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Somerville, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2534-2018