FDA Medical Device Recalls (openFDA)
Plus Orthopedics: UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
- Recall number
- Z-0540-05
- Recalling firm
- Plus Orthopedics
- Product
- UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
- Status
- Terminated
- Initiated
- 2005-01-04
- Posted
- 2005-02-15
- Terminated
- 2005-03-03
- Reason
- Knee tibial insert is mislabeled completely as different device.
- Root cause
- Other
- Action
- PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert.
- Quantity
- 10, 1 is implanted.
- Distribution
- California, Idaho, Illinois, Wisconsin, Oregon
- Lot, serial or model codes
- All of specific lot 044843
- 510(k) numbers
- ["K022204"]
- PMA numbers
- not on file
- Product code
- JWH
- 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