FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
- Recall number
- Z-0332-06
- Recalling firm
- Encore Medical, Lp
- Product
- Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
- Status
- Terminated
- Initiated
- 2005-11-03
- Posted
- 2005-12-29
- Terminated
- 2008-04-04
- Reason
- The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
- Root cause
- Other
- Action
- Firm initiated recall on 11/03/05 via letter to all consignees.
- Quantity
- 14 units.
- Distribution
- Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.
- Lot, serial or model codes
- Lot #434322.
- 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