# FDA recall Z-0715-2022

> **Stryker Leibinger GmbH & Co. KG** · Class II · device recall initiated 2021-12-29.

## Product

MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

## Reason for recall

Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-0715-2022
- **Recalling firm:** Stryker Leibinger GmbH & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-29
- **Report date:** 2022-03-09
- **Termination date:** 2023-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg Im Breisgau, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0715-2022

## Citation

> AI Analytics. FDA recall Z-0715-2022. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0715-2022. Source: US FDA. Licensed CC0.

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