FDA Medical Device Recalls (openFDA)
Plus Orthopedics: TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
- Recall number
- Z-0170-04
- Recalling firm
- Plus Orthopedics
- Product
- TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
- Status
- Terminated
- Initiated
- 2002-09-09
- Posted
- 2003-11-27
- Terminated
- 2003-12-30
- Reason
- Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
- Root cause
- Other
- Action
- Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer.
- Quantity
- 5
- Distribution
- TX,
- Lot, serial or model codes
- Lot 0006.13.2635
- 510(k) numbers
- not on file
- 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