# FDA recall Z-0621-2018

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

## Product

ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0  ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5  ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0  ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5   ELAN 4 1-RING NEURO CUTTER SOFT D3.0  ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0  ELAN 4 1-RING NEURO CUTTER D2.0   ELAN 4 1-RING NEURO CUTTER D2.5   ELAN 4 1-RING NEURO CUTTER D3.0   ELAN 4 1-RING NEURO CUTTER TC D3.0  ELAN 4 1-RING NEURO CUTTER DIAM.D1.5  ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5  ELAN 4 1-RING NEURO CUTTER DIAM.D2.0  ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0  ELAN 4 1-RING NEURO CUTTER DIAM.D2.5  ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5  ELAN 4 1-RING NEURO CUTTER DIAM.D3.0  ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0  ELAN 4 1-RING NEURO CUTTER DIAM.D4.0  ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0  ELAN 4 2-RING CRANIOTOME CUTTER PAED  ELAN 4 2-RING CRANIOTOME CUTTER STANDARD  ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED  ELAN 4 2-RING CRANIOTOME CUTTER STANDARD  ELAN 4 2-RING CRANIOTOME CUTTER LONG  EL

## 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-0621-2018
- **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-0621-2018

## Citation

> AI Analytics. FDA recall Z-0621-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0621-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*