Zimmer Dermatone AN, Model No. 88710100
Reported: August 8, 2018 Initiated: June 8, 2018 #Z-2602-2018
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.
Details
- Recalling Firm
- Zimmer Surgical Inc
- Units Affected
- 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.
- Location
- Dover, OH
Frequently Asked Questions
What product was recalled? ▼
Zimmer Dermatone AN, Model No. 88710100. Recalled by Zimmer Surgical Inc. Units affected: 140.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2018. Severity: Moderate. Recall number: Z-2602-2018.
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