Zimmer Dermatome Blades recalled for producing thin, non-uniform skin grafts
Zimmer Surgical is recalling dermatome blades that produce thin, non-uniform skin grafts during surgical use. The defect may require additional surgical harvests to adequately cover grafting sites.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall involving a surgical instrument with a functional defect. While no illnesses or injuries are explicitly reported, the blades fail to produce uniform skin grafts as intended, representing a risk-of-harm product in a surgical setting that requires additional surgical procedures.
Plain-English summary
Zimmer Surgical Inc is recalling Zimmer Dermatome Blades due to a manufacturing defect that affects product performance. These blades are used with dermatome handpieces, surgical instruments designed to harvest skin grafts with variable thickness and width. Approximately 11,985 boxes containing 119,850 blades have been distributed nationwide in the United States and internationally to Australia, Brazil, China, Hong Kong, India, Japan, Malaysia, Mexico, the Netherlands, Singapore, Taiwan, and Thailand.
The affected blades produce skin grafts that are thinner and more uneven than intended. The issue is identified at the time of surgical use and may result in the need for additional graft harvests to adequately cover the surgical site.
Healthcare facilities should verify their inventory using the affected lot numbers and product codes provided in the recall notice to identify potentially affected dermatome blades.
The recalled product
- Product
- Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
- Manufacturer
- Zimmer Surgical Inc
Distribution
Distributed nationwide across the United States.
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