FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
- Recall number
- Z-2967-2018
- Recalling firm
- Encore Medical, Lp
- Product
- Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
- Status
- Terminated
- Initiated
- 2018-05-14
- Posted
- not on file
- Terminated
- 2020-08-17
- Reason
- After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
- Root cause
- No Marketing Application
- Action
- The firm, DJO, sent an "URGENT FIELD SAFETY NOTICE" letter dated 5/14/2018 to it's customers via email, on May 14, 2018 and contained the following information: Description of Issue, Quantity in Field, product information and code, Action required, and an Acknowledgement form with contact information. The customers were instructed to: check your inventory for part number 220-10-110; Customer Service has already requested that these be quarantined by your agency; Contact Customer Service to request an RMA for return of these devices. As there are no currently cleared 10x100 femoral stem extensions, there is no product available for replacement; and complete the attached acknowledgment form, even if you do not have the affected product, and email the form to sandra.busick@djoglobal.com by May 18, 2018. Modular Femoral Cemented Stem -- 220-10-110 -determined that this device does not have FDA clearance. If you have any questions, please contact Manager, Regulatory Affairs at (512) 834-6255 or by email at teffany.hutto@djoglobal.com.
- Quantity
- 12
- Distribution
- U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
- Lot, serial or model codes
- All. Lots-866A1011, 866A1022
- 510(k) numbers
- not on file
- 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