Recall Z-2672-2020 · NKB Thoracolumbosacral Pedicle Screw System
U&I CORP.
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
| Date | May 26, 2020 |
| Status | Terminated |
| Reason | 6.0x50mm poly-reduction screws were laser etched 6.0x45 |
| Root cause | Process control |
| Action | 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. |
| Quantity | 6 |
| Distribution | U.S.: AZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173524 | ANAX 5.5 Spinal System U&I Corporation, Dec 13, 2017 |