FDA Medical Device Recalls (openFDA)
Plus Orthopedics USA: UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
- Recall number
- Z-0192-2007
- Recalling firm
- Plus Orthopedics USA
- Product
- UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
- Status
- Terminated
- Initiated
- 2006-07-18
- Posted
- 2006-11-16
- Terminated
- 2007-12-13
- Reason
- The modified devices were distributed by Plus Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special 510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003.
- Root cause
- Other
- Action
- The depth of the withdrawal action taken in June, 2003 was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.
- Quantity
- 12
- Distribution
- California
- Lot, serial or model codes
- 26014: Lot number 0305.13.2814, 26016: Lot number 0305.13.2815, 26018: Lot number 0305.13.2816, 26020: Lot number 0305.13.2817 Serial Number: None
- 510(k) numbers
- ["K032052"]
- PMA numbers
- not on file
- Product code
- HRY
- Firm FEI
- 3001237832
- Firm city
- San Diego
- Firm state
- CA
- 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