3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Reported: February 21, 2024 Initiated: January 2, 2024 #Z-1078-2024
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.
Details
- Recalling Firm
- Zimmer Surgical Inc
- Units Affected
- 76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS
- 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.
- Location
- Dover, OH
Frequently Asked Questions
What product was recalled? ▼
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier. Recalled by Zimmer Surgical Inc. Units affected: 76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2024. Severity: Moderate. Recall number: Z-1078-2024.
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