Z-2211-2016Class II

Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is...

Name: Z-2211-2016 Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is...
Creator: Devicor Medical Products Inc
Published: 2016-05-19
License: https://open.fda.gov/license/

Devicor Medical Products Inc / initiated 2016-05-19 / Terminated / root cause: packaging

FDA source

Devicor Medical Products Inc began a recall of Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered... on 2016-05-19. FDA classified it as Class II and gives the reason as "A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2211-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-19
Posted: 2016-07-14
Terminated: 2017-08-03
Recalling firm: Devicor Medical Products Inc
Product: Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
Product code: OIJ Biopsy Needle Guide Kit
Reason for recall: A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
Root cause tag: packaging
FDA root cause: Packaging
Action: An Urgent: Medical Device Recall of Mammotome Revolve Dual Vacuum Assist Biopsy Probe due to Potential Product Code Mislabel communication was sent to the customers via 1st class USPS on June 6, 2016. The labeling and the Customer response form was also attached. Customers were asked to examine their inventory and quarantine the affected product. If the product was further distributed, those customers are to be identified and notified. The letter stated that the assigned sales rep would be in contact to support the identification, inspection and replacement of the recalled products. Customers are to complete and return the enclosed response form. Questions are to be directed to Mammatome Customer Service 1-877-926-2666.
Quantity in commerce: F11537107D1 = 360; F11536423D1 = 80; F11537109D1 = 360
Distribution: Worldwide Distribution -- USA, including the states of AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, PA, SC, TN, WA and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.
Product codes and lots: MST1009 - Lot F11537107D1 Exp. Date 9-Sept, 2018; MST0815 Lot F11536423D1 Exp. Date 8-Sept, 2018; and, MST1009 Lot F11537109D1 Exp. Date 10-Sept, 2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2211-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2211-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-14

Product code OIJ

K123259Class IIMammotome Reolve Dual Vacuum Assisted Biopsy (Vab) SystemDevicor Medical Products, Inc. / cleared 2012-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)