FDA Medical Device Recalls (openFDA)
Encore Medical, LP: Foundation Knee System, non-porous Femur Size 8, Right
- Recall number
- Z-1069-03
- Recalling firm
- Encore Medical, LP
- Product
- Foundation Knee System, non-porous Femur Size 8, Right
- Status
- Terminated
- Initiated
- 2003-04-24
- Posted
- 2003-07-30
- Terminated
- 2003-07-29
- Reason
- Product container was labeled incorrectly indicating left femur instead of right.
- Root cause
- Other
- Action
- The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.
- Quantity
- 14 unimplanted units
- Distribution
- PA, TX, MA, FL, NV, AZ, and France and Saudi Arabia
- Lot, serial or model codes
- Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611
- 510(k) numbers
- ["K923277"]
- 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