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Zimmer Surgical Inc recalls Zimmer Dermatone AN, Model No. 88710100
Recalled August 8, 2018 · FDA recall Z-2602-2018 · Zimmer Surgical
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. · FDA Class II
Units
140
Sold at
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.
Description
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.
Product
Zimmer Dermatone AN, Model No. 88710100
Manufacturer(s)
Zimmer Surgical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →