FDA-Device2018-08-08Class II
Zimmer Dermatone AN, Model No. 88710100
Zimmer Surgical Inc
Hazard
Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. Potential risks include harvesting a skin graft of a thickness much greater than intended, described as patient gouged, minor delay of surgery, and sub-optimal (but usable) graft.
Sold states
Distributors in AL, AZ, CA, FL, IA, IL, MA, MI, MN, MS, NH, NJ, NY, OH, RI, SD, and TX. Foreign distribution to Canada, Australia, China, and Netherlands.
Affected count
140
Manufactured in
200 W Ohio Ave, N/A, Dover, OH, United States
Products
Zimmer Dermatone AN, Model No. 88710100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2602-2018Don't want to check this manually?
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