# FDA recall Z-0619-2018

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2017-09-05.

## Product

ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6  ELAN 4 1-RING ROSEN BURR+ D0.8  ELAN 4 1-RING ROSEN BURR D1.0  ELAN 4 1-RING ROSEN BURR TC D1.0  ELAN 4 1-RING ROSENBURR+ D1.0  ELAN 4 1-RING ROSEN BURR D1.4  ELAN 4 1-RING ROSENBURR+ D1.4  ELAN 4 1-RING ROSEN BURR D1.8  ELAN 4 1-RING ROSEN BURR+ D1.8  ELAN 4 1-RING ROSEN BURR TC D2.0  ELAN 4 1-RING ROSEN BURR D2.3  ELAN 4 1-RING ROSEN BURR+ D2.3  ELAN 4 1-RING ROSEN BURR D2.7  ELAN 4 1-RING ROSEN BURR+ D2.7  ELAN 4 1-RING ROSEN BURR D3.0  ELAN 4 1-RING ROSEN BURR TC D3.0  ELAN 4 1-RING ROSEN BURR D3.5

## Reason for recall

ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

## Distribution

Distributed to 4 hospitals in the following states: NM, OH, TX, WV

## Key facts

- **Recall number:** Z-0619-2018
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-05
- **Report date:** 2018-02-21
- **Termination date:** 2019-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0619-2018

## Citation

> AI Analytics. FDA recall Z-0619-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0619-2018. Source: US FDA. Licensed CC0.

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