Zimmer Air Dermatome II Handpiece Recalled for Surface Coating Defects
Zimmer Biomet Surgical is recalling Air Dermatome II Handpiece loaners because the surface coating may blister, peel, or discolor over time. No injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that no injuries have been reported and an independent assessment found no expected long-range health consequences, fitting the criteria for a voluntary precautionary recall with low-risk contamination.
Plain-English summary
Zimmer Biomet Surgical is recalling 1,030 units of the Zimmer Air Dermatome II Handpiece Loaner (item number 01-8851-001-00) due to product complaints regarding the device's surface coating. The coating has been reported to blister, peel, and discolor after usage over time. The devices were distributed nationwide across 38 states.
The recall is precautionary. Zimmer Biomet Surgical states that there have been no injuries associated with the reported complaints. An independent assessment determined that the blistering, peeling, and potential flaking of the surface coating is not expected to result in any long-range health consequences. The company is preparing replacement activities to prevent future complaints.
Users of the affected devices should not return the product at this time. A separate recall removal notice with detailed instructions will be issued to facilities in phases beginning in August 2016. Sales representatives will notify facilities when a replacement is ready.
The recalled product
- Product
- Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then pl
- Manufacturer
- Zimmer Surgical Inc
- Affected units
- 1,030
Distribution
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