PlainRecalls
FDA Devices Moderate Class II Ongoing

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.