medical Class II Updated 2018-08-08

Zimmer Surgical Inc recalls Zimmer Dermatone AN, Model No. 88710100

Recalled Product

Zimmer Dermatone AN, Model No. 88710100


Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AZ, CA, FL, IA, IL, MA, MI, MN, MS, NH, NJ, NY, OH, RI, SD, TX
Lot/Code Info: Lots 63578134 , 63578135, 63592351, 63618116, 63646910, 63817639, 63898373
View official government recall

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