FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
- Recall number
- Z-1255-2010
- Recalling firm
- Encore Medical, Lp
- Product
- Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
- Status
- Terminated
- Initiated
- 2010-02-22
- Posted
- 2010-04-07
- Terminated
- 2010-07-22
- Reason
- One lot of product was incorrectly manufactured. Pegs are larger than specification.
- Root cause
- Process control
- Action
- Firm notified consignees by e-mail on 2/22/2010.
- Quantity
- 2 units
- Distribution
- United States (FL and ID).
- Lot, serial or model codes
- Part Number 802-01-019 Lot 53944551
- 510(k) numbers
- ["K932246"]
- 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