# FDA recall Z-1510-2021

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2021-04-08.

## Product

CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208

## Reason for recall

Mislabeled box contained  a 6mm x 20mm screw instead of  6mm x 30mm screw

## Distribution

Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.

## Key facts

- **Recall number:** Z-1510-2021
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-08
- **Report date:** 2021-05-05
- **Termination date:** 2022-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2021

## Citation

> AI Analytics. FDA recall Z-1510-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1510-2021. Source: US FDA. Licensed CC0.

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