Z-3066-2017Class II

Tissu-Trans SFILL 360, 3-TT-SFILL 360

Name: Z-3066-2017 Tissu-Trans SFILL 360, 3-TT-SFILL 360
Creator: Shippert Medical Technologies
Published: 2017-06-01
License: https://open.fda.gov/license/

Summit Medical, LLC / initiated 2017-06-01 / Terminated / root cause: packaging

FDA source

Shippert Medical Technologies began a recall of Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction on 2017-06-01. FDA classified it as Class II and gives the reason as "Seal integrity of the Tissu-Trans product sterile packages cannot be assured". 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-3066-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-01
Posted: 2017-08-22
Terminated: 2024-01-30
Recalling firm: Summit Medical, LLC
Product: Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
Product code: N/A
Reason for recall: Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
Root cause tag: packaging
FDA root cause: Packaging
Action: Customers were notified of the recall between 06/01/2017 and 06/14/2017 via FedEx letter. Instructions included remove and quarantine all affected devices, complete and return the response form, arrange for the return of affected devices, and notify any customers if further distributed.
Quantity in commerce: 5,188 units total
Distribution: Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WV. and the countries of: Italy, Austria, Turkey, United Arab Emirates, Germany, Spain, Saudi Arabia, Switzerland, Japan Kuwait, Denmark, Sweden, United Kingdom, Belgium, France, Australia, Netherlands, Greece, South Korea.
Product codes and lots: Lot Numbers 12079, 61117, 61143, 61405.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3066-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3060-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-22
Z-3061-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-22
Z-3062-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-22
Z-3063-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-22
Z-3064-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-22
Z-3065-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-22
Z-3066-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-22

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)