FDA Medical Device Recalls (openFDA)
U&I America: Optima Spinal System and Spinal Hook System, set screw component.
- Recall number
- Z-1438-04
- Recalling firm
- U&I America
- Product
- Optima Spinal System and Spinal Hook System, set screw component.
- Status
- Terminated
- Initiated
- 2004-08-10
- Posted
- 2004-09-08
- Terminated
- 2005-11-29
- Reason
- Threads on a set screw, as a component of a spinal fixation system, may break off during use.
- Root cause
- Other
- Action
- Consignee was notified by letter on 08/10/2004.
- Quantity
- 200 set screws
- Distribution
- CA
- Lot, serial or model codes
- Part number SP3020 (revision 6), Lot # 04D033.
- 510(k) numbers
- ["K020279","K024096","K031585","K031595"]
- 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