FDA recall Z-2672-2020
U&I CORP. · Class II · device
Product
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Reason for recall
6.0x50mm poly-reduction screws were laser etched 6.0x45
Distribution
U.S.: AZ
Key facts
- Status
- Terminated
- Initiation date
- 2020-05-26
- Report date
- 2020-07-29
- Termination date
- 2024-04-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Uijeongbu, N/A, Korea (the Republic of)
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2672-2020