FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
- Recall number
- Z-0826-2010
- Recalling firm
- Encore Medical, Lp
- Product
- Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
- Status
- Terminated
- Initiated
- 2009-12-11
- Posted
- 2010-02-24
- Terminated
- 2010-09-24
- Reason
- Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method.
- Root cause
- Process control
- Action
- Firm notified consignees by letter on 12/11/2009. The letter informs physicians that patients with implanted devices should counseled about the issue and should report any changes to their treating physician.
- Quantity
- 17
- Distribution
- TX, FL, GA, CA, AZ, Japan
- Lot, serial or model codes
- Lot 53944312
- 510(k) numbers
- ["K932425"]
- 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