Class II

Medical Device Recall: 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier

Zimmer Surgical Inc · January 2, 2024

Reason for Recall

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.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1078-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.