# FDA recall Z-1614-2023

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2023-04-11.

## Product

Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device.  Part Number: 82-6607

## Reason for recall

Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.

## Distribution

PA  Foreign: Australia, Belgium

## Key facts

- **Recall number:** Z-1614-2023
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-11
- **Report date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1614-2023

## Citation

> AI Analytics. FDA recall Z-1614-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1614-2023. Source: US FDA. Licensed CC0.

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