Recall Z-2672-2020
U&I Corp. · initiated May 26, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Codes / lots: Lot #: 19C12063
Reason for recall
6.0x50mm poly-reduction screws were laser etched 6.0x45
FDA-determined cause: Process control
Action taken
On 05/26/20, a Request to Return Products Which Have Laser Marking Issue notice was sent to the firm customer. The customer was first asked to distinguish and isolate affected product and then to return affected product. This customer/distributor sent Notification for Sales Suspension and Product Recall notices to their customers. Customers were asked to return affected product and to fill out and return the Notification for Sales Suspension and Product Recall notices to acknowledge receipt.
Details
- Recall number
- Z-2672-2020
- Initiated
- May 26, 2020
- Terminated
- April 5, 2024
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 6
- Distribution
- U.S.: AZ
- Recalling firm
- U&I Corp.