# FDA recall Z-0878-2020

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2019-12-16.

## 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.

## Distribution

USA: IA, NC, PA, TN.  Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.

## Key facts

- **Recall number:** Z-0878-2020
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-12-16
- **Report date:** 2020-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0878-2020

## Citation

> AI Analytics. FDA recall Z-0878-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0878-2020. Source: US FDA. Licensed CC0.

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