# FDA recall Z-2902-2018

> **Stryker Leibinger GmbH & Co. KG** · Class II · device recall initiated 2018-06-22.

## Product

QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2-  HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S,   for use on the cranium

## Reason for recall

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

## Distribution

US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.

## Key facts

- **Recall number:** Z-2902-2018
- **Recalling firm:** Stryker Leibinger GmbH & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-22
- **Report date:** 2018-09-05
- **Termination date:** 2019-07-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2902-2018

## Citation

> AI Analytics. FDA recall Z-2902-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2902-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*