FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
- Recall number
- Z-1539-2008
- Recalling firm
- Encore Medical, Lp
- Product
- 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
- Status
- Terminated
- Initiated
- 2008-02-20
- Posted
- 2008-08-20
- Terminated
- 2008-09-02
- Reason
- Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
- Root cause
- Error in labeling
- Action
- Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08.
- Quantity
- 6 units.
- Distribution
- Distribution --- country of Germany.
- Lot, serial or model codes
- Lot #53906407
- 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