Z-2110-2017Class II

Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

Name: Z-2110-2017 Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Creator: Molnlycke Health Care, Inc
Published: 2017-04-24
License: https://open.fda.gov/license/

Molnlycke Health Care / initiated 2017-04-24 / Open, Classified / root cause: manufacturing process

FDA source

Molnlycke Health Care, Inc began a recall of Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts' on 2017-04-24. FDA classified it as Class II and gives the reason as "Sterilization validation failure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2110-2017
Classification: Class II
Status: Open, Classified
Initiated: 2017-04-24
Posted: 2017-05-03
Recalling firm: Molnlycke Health Care
Product: Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Product code: FZW Expander, Surgical, Skin Graft
Reason for recall: Sterilization validation failure.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were notified by Urgent Safety Notice letter via certified mail on/about 4/24/2017.
Quantity in commerce: 956 units
Distribution: Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Jordan, Korea, Kuwait, Malaysia, Norway, New Zealand, Peru, Saudi Arabia, Sweden Switzerland, Taiwan, Turkey, South Africa, United Arab Emirates.
Product codes and lots: Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2110-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2110-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-05-24	2017-05-18

Product code FZW

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)