Uijeongbu-Si Gyeonggi-Do, N/A, Korea (the Republic of)
U&I CORP. recalls
2 recalls recorded since 2018, most recently on 26 May 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 May 2020
- Terminated
- 5 April 2024
- Reason
- 6.0x50mm poly-reduction screws were laser etched 6.0x45
- Distribution
- U.S.: AZ
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2672-2020
- ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Terminated Class II Medical devices
- Recall started
- 30 January 2019
- Terminated
- 20 November 2020
- Reason
- The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.
- Distribution
- US Nationwide distribution in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1823-2020
- Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletall
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.