Z-2967-2018Class II

Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision...

Name: Z-2967-2018 Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision...
Creator: Encore Medical, Lp
Published: 2018-05-14
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2018-05-14 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee... on 2018-05-14. FDA classified it as Class II and gives the reason as "After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2967-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-14
Posted: 2018-08-31
Terminated: 2020-08-17
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Root cause tag: labeling and UDI
FDA 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 [email protected] 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 [email protected].
Quantity in commerce: 12
Distribution: U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
Product codes and lots: All. Lots-866A1011, 866A1022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2967-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2967-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-08-31

Product code JWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)