# FDA recall Z-0348-2021

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2020-09-24.

## Product

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene,  I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm    Number: 00-8065-554-32

## Reason for recall

Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant.  Cannot rule out the potential for adverse tissue reactions.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-0348-2021
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-24
- **Report date:** 2020-11-11
- **Termination date:** 2022-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0348-2021

## Citation

> AI Analytics. FDA recall Z-0348-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0348-2021. Source: US FDA. Licensed CC0.

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