LEGION AP Cutting Block Size 4 — Class II medical device recall Z-0878-2020
Ongoing recall by Smith & Nephew, Inc., reported 2020-02-05, distributed in IA, NC, PA, TN. Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and th
| Recall number | Z-0878-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2019-12-16 |
| Classified | 2020-01-28 |
| Reported by FDA | 2020-02-05 |
| Distributed | IA, NC, PA, TN |
| Quantity | 59 units |
| Lot numbers | 17LM01746, 17LM05390, 17LM05394, 17LM05397, 17LM05398, 17LM05399, 17LM07849, 17LM07851, 17LM07852, 17LM07852A, 17LM08442 |
| Model numbers | 71434409, 71434411, 71434412, 71434413 |
Product
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).
Reason for recall
Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
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-0878-2020. 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.