FDA-Device2024-02-21Class II
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Zimmer Surgical Inc
Hazard
Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.
Sold states
Worldwide - US Nationwide distribution including in the states of CA, DE, FL, GA, IA, IL, IN, KS, LA, MI, MO, MT, NC, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV and the countries of AUTRALIA, CANADA, DNIPRO OBLAS, HONG KONG, INDIA, JAPAN, MEXICO, CDMX, NETHERLANDS, SEOUL KOREA, SINGAPORE, TAIWAN, THAILAND.
Affected count
76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS
Manufactured in
200 W Ohio Ave, N/A, Dover, OH, United States
Products
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2024Don't want to check this manually?
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