Reported May 24, 2017 · Ongoing

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

Molnlycke Health Care, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Molnlycke Health Care, Inc · 5550 Peachtree Pkwy Ste 500 · Norcross, GA · 30092-2555

Is this the product you have?

  • Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Lot codes and dates
  • Code
    • 131600
    • 131601
    • 131602
    • 131603
    • 131604
    • 131500
    • 131501
    • 131502
    • 131503
    • 131504 and 131506
Amount recalled
956 units

Where it was sold

  • Nationwide

Why it was recalled

Sterilization validation failure.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:16 PM UTC

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