FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block — Class II medical device recall Z-2262-2015
Terminated recall by Encore Medical, Lp, reported 2015-08-05, distributed in GA, TX. The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anterior and Poster
| Recall number | Z-2262-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2015-06-24 |
| Classified | 2015-07-27 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2016-06-24 |
| Distributed | GA, TX |
| Quantity | 10 units |
| Lot numbers | 414012, 53839799 |
| Model numbers | 800-01-139 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2262-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.