Z-0657-2020 Class II Ongoing
FDA device recall Z-0657-2020 was initiated by Medtronic Navigation, Inc. on October 30, 2019 and is designated Class II. 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 tig… The recall status is ongoing. Affected quantity: 10,448 disposable biopsy needles.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- October 30, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,448 disposable biopsy needles
Product Description
Reason for Recall
Distribution Pattern
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,Slovakia,Slovenia,South Africa,Spain,Sweden,Switzerland,Thailand,Turkey,United Arab Emirates,United Kingdom