# FDA recall Z-2389-2021

> **Aspen Surgical Products, Inc.** · Class II · device recall initiated 2021-07-23.

## Product

Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100

## Reason for recall

Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.

## Distribution

US nationwide distribution. No foreign distribution.

## Key facts

- **Recall number:** Z-2389-2021
- **Recalling firm:** Aspen Surgical Products, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-23
- **Report date:** 2021-09-08
- **Termination date:** 2022-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Caledonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2389-2021

## Citation

> AI Analytics. FDA recall Z-2389-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2389-2021. Source: US FDA. Licensed CC0.

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