FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
- Recall number
- Z-2244-2010
- Recalling firm
- Encore Medical, Lp
- Product
- 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
- Status
- Terminated
- Initiated
- 2010-06-28
- Posted
- 2010-08-22
- Terminated
- 2010-10-04
- Reason
- One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing.
- Root cause
- Labeling mix-ups
- Action
- Firm notified their consignees by letter on June 28, 2010.
- Quantity
- 18
- Distribution
- Florida, Missouri, and Italy
- Lot, serial or model codes
- Size 8, Left, Part # 333-01-108, Lot# A1000003
- 510(k) numbers
- ["K020114"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- 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