Z-2262-2015Class II

FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

Name: Z-2262-2015 FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Creator: Encore Medical, Lp
Published: 2015-06-24
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2015-06-24 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139 on 2015-06-24. FDA classified it as Class II and gives the reason as "The markings on the distal face of the instruments are mis-oriented by 180. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2262-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Posted: 2015-07-27
Terminated: 2016-06-24
Recalling firm: Encore Medical, LP
Product: FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Product code: HWT Template
Reason for recall: The markings on the distal face of the instruments are mis-oriented by 180. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the A/P direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant.
Root cause tag: design
FDA root cause: Component design/selection
Action: DJO Surgical sent an " Urgent Field Safety Notice" dated June 30, 2015, to the affected customer. The recalling firm requested the customer return the affected product for a replacement. For further questions, please call (512) 834-6302.
Quantity in commerce: 10 units
Distribution: US Distribution to TX and GA.
Product codes and lots: Lot 53839799 and 414012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2262-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2262-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-27

Product code HWT

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)