Z-1078-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2024
- Initiation Date
- January 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS
Product Description
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
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 Pattern
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.
Code Information
UDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027)