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FDAJune 8, 2018device

Zimmer Dermatone AN, Model No. 88710100

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

zimmer surgicalzimmer

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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