U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu Korea (the Republic of) ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Brand
U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu Korea (the Republic of)
Lot Codes / Batch Numbers
Lot #: 19C12063
Products Sold
Lot #: 19C12063
U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu Korea (the Republic of) is recalling ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM due to 6.0x50mm poly-reduction screws were laser etched 6.0x45. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
6.0x50mm poly-reduction screws were laser etched 6.0x45
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ
Page updated: Jan 10, 2026