Reported Aug 8, 2018 · Terminated
Zimmer Dermatone AN, Model No. 88710100
Zimmer Surgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Surgical Inc · 200 W Ohio Ave · Dover, OH · 44622-9642
Is this the product you have?
- Zimmer Dermatone AN, Model No. 88710100
- Lot codes and dates
Lots 63578134635781356359235163618116636469106381763963898373
- Amount recalled
- 140
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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