Z-2262-2015 Class II Terminated
FDA device recall Z-2262-2015 was initiated by Encore Medical, Lp on Jun 24, 2015 and is designated Class II. 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 recall status is terminated (terminated Jun 24, 2016). Affected quantity: 10 units.
Recall details
- Product Type
- Devices
- Report Date
- Aug 5, 2015
- Initiation Date
- Jun 24, 2015
- Termination Date
- Jun 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product description
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
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.
Distribution pattern
US Distribution to TX and GA.
Code information
Lot 53839799 and 414012
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2262-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026