FDA Medical Device Recalls (openFDA)
U&I America: Optima Poly Screw Driver.
- Recall number
- Z-1182-03
- Recalling firm
- U&I America
- Product
- Optima Poly Screw Driver.
- Status
- Terminated
- Initiated
- 2003-08-18
- Posted
- 2003-08-27
- Terminated
- 2003-11-19
- Reason
- Reports of pieces chipping off the tip of screwdriver during use.
- Root cause
- Other
- Action
- Consignee was notified by letter on 8/18/2003
- Quantity
- 215 units.
- Distribution
- MN
- Lot, serial or model codes
- Part OP20002 Revision C, Lot No. 03030301 and 05120308.
- 510(k) numbers
- ["K020279","K031585"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3003200830
- Firm city
- Murray
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28