Z-1147-2018Class II

DERMABOND" PRINEO" Skin Closure System

Name: Z-1147-2018 DERMABOND" PRINEO" Skin Closure System
Creator: Ethicon, Inc.
Published: 2017-11-27
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2017-11-27 / Terminated

FDA source

Ethicon, Inc. began a recall of DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin... on 2017-11-27. FDA classified it as Class II and gives the reason as "Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1147-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-27
Posted: 2018-03-21
Terminated: 2019-04-30
Recalling firm: Ethicon, Inc
Product: DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound durinQ application of the liquid adhesive
Product code: OMO
Reason for recall: Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.
FDA root cause: Component change control
Action: Ethicon sent an URGENT MEDICAL DEVICE RECALL REMOVAL letter dated November 2017 to customers titled: "DERMABONDTM PRINEOTM SKIN CLOSURE SYSTEM (22 CM)". The letter identified the affected product, problem and action to be taken. The letter instructed customers to do not use or distribute any product which is subject to recall. Customers are asked to examine inventory, quarantine products that are subject to recall and contact the firm for return of product. Also, post the recall letter in a visible location at facility. If you have additional questions regarding this recall (removal) or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.
Quantity in commerce: 20,090 eaches (10,545 units)
Distribution: US Nationwide Distribution
Product codes and lots: LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1147-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1147-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-20

Product code OMO

K133864Class IIDermabond Prineo Skin Closure SystemETHICON, Inc. / cleared 2014-03-10

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)