FDA Medical Device Recalls (openFDA)
Plus Endoprothetik AG: TC-PLUS Solution Tibial Component-- Symmetric
- Recall number
- Z-0017-04
- Recalling firm
- Plus Endoprothetik AG
- Product
- TC-PLUS Solution Tibial Component-- Symmetric
- Status
- Terminated
- Initiated
- 2003-04-17
- Posted
- 2003-10-15
- Terminated
- 2003-12-03
- Reason
- Labeling/packaging mix-up.
- Root cause
- Other
- Action
- Firm notified implanting surgeons by letter and telephone on May 16, 2003 and on June 2, 2003. One physician was contacted on August 26, 2003. The firm communicated the need to follow-up with the patients . Recall is complete.
- Quantity
- 15
- Distribution
- TX, CA, VA, ID, NY, UT, FL
- Lot, serial or model codes
- Lot 0211.13.4553
- 510(k) numbers
- ["K000666"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3002807898
- Firm city
- Rotkreuz
- Firm state
- not on file
- Firm country
- Switzerland
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