# FDA recall Z-0617-2018

> **Synthes USA** · Class II · device recall initiated 2017-08-10.

## Product

Norian Drillable Inject

## Reason for recall

The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

## Distribution

Nationwide Distribution.

## Key facts

- **Recall number:** Z-0617-2018
- **Recalling firm:** Synthes USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-10
- **Report date:** 2018-02-21
- **Termination date:** 2018-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0617-2018

## Citation

> AI Analytics. FDA recall Z-0617-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0617-2018. Source: US FDA. Licensed CC0.

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