# FDA recall Z-0826-2019

> **Ottobock Orthopedic Industrie** · Class II · device recall initiated 2019-01-10.

## Product

21Y14 PushValve    Product Usage:    The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.

## Reason for recall

Some of the installed valve-inserts have a diameter smaller than the specification.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0826-2019
- **Recalling firm:** Ottobock Orthopedic Industrie
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-10
- **Report date:** 2019-02-20
- **Termination date:** 2021-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Duderstadt, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2019

## Citation

> AI Analytics. FDA recall Z-0826-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0826-2019. Source: US FDA. Licensed CC0.

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