FDA recall Z-1335-2020
Ethicon, Inc. · Class II · device
Product
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
Reason for recall
The product do not meet certain internal testing specifications.
Distribution
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
Key facts
- Status
- Terminated
- Initiation date
- 2019-08-28
- Report date
- 2020-02-26
- Termination date
- 2021-02-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Somerville, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1335-2020