Zimmer Dermatone AN Skin Graft Device Recalled for Loose Control Bar
Zimmer Surgical Inc is recalling 140 units of the Zimmer Dermatone AN skin graft device due to a loose control bar that may compromise graft thickness control.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes specific patient harm ("patient gouged") and surgical delays, which aligns with the rubric for risk-of-harm products where injury has not yet been reported as a formal injury count but is described as a potential risk.
Plain-English summary
Zimmer Surgical Inc is recalling 140 units of the Zimmer Dermatone AN, Model No. 88710100, a skin graft harvesting device. The recall is due to a potential defect where the control bar may be loose, which could compromise the device's ability to control the thickness of the skin graft. Additionally, the device may have a loose width plate that, if undetected, could result in an imperfect, though still usable, graft.
The potential risks associated with this defect include harvesting a skin graft that is much thicker than intended, which has been described as "patient gouged." Other reported consequences include a minor delay in surgery and the creation of a sub-optimal but usable graft. The affected lots are 63578134, 63578135, 63592351, 63618116, 63646910, 63817639, and 63898373.
The devices were distributed to distributors in Alabama, Arizona, California, Florida, Iowa, Illinois, Massachusetts, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Rhode Island, South Dakota, and Texas. Foreign distribution included Canada, Australia, China, and the Netherlands. Users should contact Zimmer Surgical Inc for instructions on how to return the device or obtain a replacement.
The recalled product
- Product
- Zimmer Dermatone AN, Model No. 88710100
- Manufacturer
- Zimmer Surgical Inc
- Affected units
- 140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lots 63578134
- 63578135
- 63592351
- 63618116
- 63646910
- 63817639
- 63898373
Distribution
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