Stride Femoral Component Size 2 — Class II medical device recall Z-1943-2014
Terminated recall by Blue Belt Technologies MN, reported 2014-07-09, distributed nationwide. Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left late
| Recall number | Z-1943-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blue Belt Technologies MN, Plymouth, MN, United States |
| Recall initiated | 2014-06-04 |
| Classified | 2014-06-27 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2014-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | labeling |
| Lot numbers | C785241 |
| Expiration dates | 2015-04 |
Product
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Reason for recall
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.
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-1943-2014. 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.