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

Recall date

June 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2602-2018

FDA classification

Class II

Brand / firm

Zimmer Surgical Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zimmer Dermatone AN, Model No. 88710100