# FDA recall Z-0176-2023

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2022-09-20.

## Product

C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,

## Reason for recall

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

## Distribution

MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

## Key facts

- **Recall number:** Z-0176-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-20
- **Report date:** 2022-11-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2023

## Citation

> AI Analytics. FDA recall Z-0176-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0176-2023. Source: US FDA. Licensed CC0.

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