FDA Recall
Terminated
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Recall: Z-2672-2020
·
Initiated May 26, 2020
Recall
- Recall Number
- Z-2672-2020
- Event Number
- 85841
- Firm
- U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu Korea (the Republic of)
- FEI Number
- 3003200961
- Product Code
- NKB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 26, 2020
- Terminated
- April 5, 2024
Description
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Reason
6.0x50mm poly-reduction screws were laser etched 6.0x45
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.
Distribution
U.S.: AZ
Quantity
6