U & I America Optima Spinal System and Spinal Hook System, set screw component. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Optima Spinal System and Spinal Hook System, set screw component.
Brand
U & I America
Lot Codes / Batch Numbers
Part number SP3020 (revision 6), Lot # 04D033.
Products Sold
Part number SP3020 (revision 6), Lot # 04D033.
U & I America is recalling Optima Spinal System and Spinal Hook System, set screw component. due to Threads on a set screw, as a component of a spinal fixation system, may break off during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Threads on a set screw, as a component of a spinal fixation system, may break off during use.
Recommended Action
Per FDA guidance
Consignee was notified by letter on 08/10/2004.
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
CA
Page updated: Jan 10, 2026