# FDA recall Z-0548-2021

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2020-11-11.

## Product

Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000

## Reason for recall

Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia,  Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.

## Key facts

- **Recall number:** Z-0548-2021
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-11
- **Report date:** 2020-12-16
- **Termination date:** 2021-06-17

- **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-0548-2021

## Citation

> AI Analytics. FDA recall Z-0548-2021. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-0548-2021. Source: US FDA. Licensed CC0.

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