# FDA recall Z-0457-2021

> **Stryker GmbH** · Class II · device recall initiated 2020-09-25.

## Product

Osteosynthesis Compression Staple EasyClip

## Reason for recall

The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.

## Distribution

The devices were distributed nationwide throughout the US, and to countries OUS.    Easy Clip devices:  As of 09/04/2020, 251,566 EasyClip devices have been manufactured. 121,517 of those devices were distributed to the US, and 102,529 were distributed in countries OUS. 27,520 devices were left in the firm's inventory.    Easy Clip Xpress devices:  As of 09/04/2020, 37,371 EasyClip Xpress devices have been manufactured. 9,561 of those devices were distributed to the US, leaving 27,810 in the firm's inventory. This device is only distributed in the United States.

## Key facts

- **Recall number:** Z-0457-2021
- **Recalling firm:** Stryker GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-25
- **Report date:** 2020-11-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Selzach, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0457-2021

## Citation

> AI Analytics. FDA recall Z-0457-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0457-2021. Source: US FDA. Licensed CC0.

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