FDA recall Z-2602-2018

Zimmer Surgical Inc · Class II · device

Product

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

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.

Key facts

Status
Terminated
Initiation date
2018-06-08
Report date
2018-08-08
Termination date
2019-07-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dover, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2602-2018