Z-2602-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- June 8, 2018
- Termination Date
- July 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 140
Product Description
Zimmer Dermatone AN, Model No. 88710100
Reason for Recall
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.
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.
Code Information
Lots 63578134 , 63578135, 63592351, 63618116, 63646910, 63817639, 63898373