Zimmer Dermatone AN recall
Zimmer Dermatone AN, Model No. 88710100
Why was Zimmer Dermatone AN 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots 63578134 , 63578135, 63592351, 63618116, 63646910, 63817639, 63898373
- Product
- Zimmer Dermatone AN, Model No. 88710100
- Recalling firm
- Zimmer Surgical Inc
- Quantity
- 140
- 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.
- Recall date
- August 8, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)