Z-0170-2018Class II

Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction

Name: Z-0170-2018 Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction
Creator: Shippert Medical Technologies
Published: 2017-10-20
License: https://open.fda.gov/license/

Summit Medical, LLC / initiated 2017-10-20 / Terminated / root cause: packaging

FDA source

Shippert Medical Technologies began a recall of Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction on 2017-10-20. FDA classified it as Class II and gives the reason as "Potential breach of sterility of the packaging". 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-0170-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-20
Posted: 2017-11-22
Terminated: 2018-10-09
Recalling firm: Summit Medical, LLC
Product: Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
Product code: MUU System, Suction, Lipoplasty
Reason for recall: Potential breach of sterility of the packaging.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: A n Urgent: Medical Device Recall letter, dated October 20, 2017, was mailed to the user, identifying the affected device and describing the reason for the recall. The letter also provided the risk to health involved and discussed how the user can recognize the failure. Customers were instructed to remove all affected product from their inventory and quarantine them. Additionally, the letter should be forwarded to all necessary staff. Customers are to complete the Recall Response letter within 10 calendar days. Only the affected products listed should be returned per the instructions provided. Questions should be directed to Customer Service at 800-888-8663.
Quantity in commerce: 56 units
Distribution: Worldwide Distribution -- United States, Australia, and Netherlands.
Product codes and lots: Lot 12004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0170-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-22

Product code MUU

K092482Class IITissu Trans Filtron, Models 3-Tt-Filtron 2000-500Shippert Medical Technologies Corp. / cleared 2009-12-04

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)