# FDA recall Z-3212-2018

> **Medtronic Neurosurgery** · Class II · device recall initiated 2018-05-03.

## Product

Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine.    REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use

## Reason for recall

The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state  Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.

## Distribution

Domestic:  AL, AZ, AR, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, LA, MD, MI, MN, MS, MO, NB, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY  OUS:  Australia, Germany, Kenya, Russian Federation, South Africa

## Key facts

- **Recall number:** Z-3212-2018
- **Recalling firm:** Medtronic Neurosurgery
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-03
- **Report date:** 2018-10-03
- **Termination date:** 2022-08-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Goleta, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3212-2018

## Citation

> AI Analytics. FDA recall Z-3212-2018. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-3212-2018. Source: US FDA. Licensed CC0.

---

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