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Recall Observatory FDA recall evidence

Device product

Zimmer Dermatone AN, Model No. 88710100

Z-2602-2018

June 08, 2018

Class II

Product summary

Firm
Zimmer Surgical Inc
Event
Event 80466
Status
Terminated
Classification
Class II
Quantity
140
Official record key
device-enforcement:Z-2602-2018

Official wording

Reason: 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.

Code information: Lots 63578134 , 63578135, 63592351, 63618116, 63646910, 63817639, 63898373

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.