# FDA recall Z-0657-2020

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2019-10-30.

## Product

Passive Biopsy Needle Kit, UDI: 00643169030121   and 00643169702943

## Reason for recall

The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop,  there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle.  This could result in a delay in surgery.

## Distribution

US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland,Massachusetts,Michigan,Minnesota,Mississippi,Missouri,Montana,Nebraska,Nevada,New Hampshire,New Jersey,New Mexico,New York,North Carolina,North Dakota,Ohio,Oklahoma,Oregon,Pennsylvania,South Carolina,South Dakota,Tennessee,Texas,Utah,Vermont,Virginia,Washington,West Virginia,Wisconsin,Wyoming,    OUS: None: Australia, Austria,Bangladesh,Belgium,Bosnia And Herzegovina,Brazil,Bulgaria,Canada,Canary Islands,China,Colombia,Costa Rica,Croatia,Czech Republic,Denmark,Ecuador,Egypt,Finland,France,Germany,Greece,Hungary,Iceland,India,Indonesia,Ireland,Israel,Italy,Japan,Jordan,Kazakhstan,Kenya,Korea, Republic Of,Latvia,Lebanon,Luxembourg,Malaysia,Martinique,Mexico,Netherlands,New Zealand,Pakistan,Philippines,Poland,Portugal,Puerto Rico,Qatar,Reunion,Romania,Russian Federation,Saudi Arabia,Serbia,Slo

## Key facts

- **Recall number:** Z-0657-2020
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-30
- **Report date:** 2019-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0657-2020

## Citation

> AI Analytics. FDA recall Z-0657-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0657-2020. Source: US FDA. Licensed CC0.

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