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Recall Observatory FDA recall evidence

Device product

3:1 Dermacarrier, Model Number 00219501300, skin graft carrier

Z-1078-2024

January 02, 2024

Class II

Product summary

Firm
Zimmer Surgical Inc
Event
Event 93790
Status
Ongoing
Classification
Class II
Quantity
76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS
Official record key
device-enforcement:Z-1078-2024

Official wording

Reason: 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.

Code information: UDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027)

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.