# FDA recall Z-1147-2018

> **Ethicon, Inc.** · Class II · device recall initiated 2017-11-27.

## 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

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1147-2018
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-27
- **Report date:** 2018-03-28
- **Termination date:** 2019-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerville, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1147-2018

## Citation

> AI Analytics. FDA recall Z-1147-2018. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1147-2018. Source: US FDA. Licensed CC0.

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