Medical Devices
U & I America Optima Poly Screw Driver. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Optima Poly Screw Driver.
Brand
U & I America
Lot Codes / Batch Numbers
Part OP20002 Revision C, Lot No. 03030301 and 05120308.
Products Sold
Part OP20002 Revision C, Lot No. 03030301 and 05120308.
U & I America is recalling Optima Poly Screw Driver. due to Reports of pieces chipping off the tip of screwdriver during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of pieces chipping off the tip of screwdriver during use.
Recommended Action
Per FDA guidance
Consignee was notified by letter on 8/18/2003
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
MN
Page updated: Jan 10, 2026