# FDA recall Z-1444-2022

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2020-09-08.

## Product

AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM,  product code SWT113T.  Used in spinal fusion surgery.

## Reason for recall

Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

## Distribution

United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.

## Key facts

- **Recall number:** Z-1444-2022
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-08
- **Report date:** 2022-07-27
- **Termination date:** 2024-04-10

- **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-1444-2022

## Citation

> AI Analytics. FDA recall Z-1444-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1444-2022. Source: US FDA. Licensed CC0.

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