FDA recall Z-0223-2020
Synthes (USA) Products LLC · Class II · device
Product
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Reason for recall
The subject product measures 4.0mm in diameter instead of 3.5mm.
Distribution
Distributed to NJ.
Key facts
- Status
- Terminated
- Initiation date
- 2019-09-16
- Report date
- 2019-11-06
- Termination date
- 2020-04-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- West Chester, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0223-2020