FDA Medical Device Recalls (openFDA)
Plus Orthopedics USA: TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
- Recall number
- Z-0126-06
- Recalling firm
- Plus Orthopedics USA
- Product
- TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
- Status
- Terminated
- Initiated
- 2005-02-22
- Posted
- 2005-11-03
- Terminated
- 2007-02-05
- Reason
- Labeling discrepancy.
- Root cause
- Other
- Action
- Firm retrieved the unit from the consignee and returned it to the manufacturer. Firm indicates that Operations contacted the agent site and requested the return.
- Quantity
- 1 unit
- Distribution
- NY
- Lot, serial or model codes
- Exp Date of 2011. No serial number. Lot number 0411.13.6556.
- 510(k) numbers
- ["K000666"]
- 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