Z-0749-2017Class II

Cellfina Prep Pack, Part No. CP1

Name: Z-0749-2017 Cellfina Prep Pack, Part No. CP1
Creator: Ulthera Inc
Published: 2016-11-14
License: https://open.fda.gov/license/

Merz North America, Inc. / initiated 2016-11-14 / Terminated / root cause: labeling and UDI

FDA source

Ulthera Inc began a recall of Cellfina Prep Pack, Part No. CP1 on 2016-11-14. FDA classified it as Class II and gives the reason as "It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0749-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-14
Posted: 2016-12-13
Terminated: 2017-09-13
Recalling firm: Merz North America, Inc.
Product: Cellfina Prep Pack, Part No. CP1
Product code: OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Reason for recall: It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Ulthera sent an Urgent Medical Device Recall letter dated November 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. Customers are informed of the actions to be taken. Customers with any technical or logistical questions are instructed to contact technical support at Ulthera, Inc. at (480) 619-4069. The letter informs the customers with questions related to their Cellfina business are instructed to contact Merz North America at 888-751-7546 or at [email protected].
Quantity in commerce: 6562 units
Distribution: Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
Product codes and lots: all

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0749-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0749-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-13

Product code OUP

K161885Class IIThe Cellfina SystemUlthera, Inc. / cleared 2016-10-05

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)