FDAFDA · Food and drugs·Recall number Z-1078-2024
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Published February 21, 2024 · Recall initiated: January 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Surgical Inc
- Distributor
- 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.
- Lot
- UDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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