Air dermatomes recalled because the thickness control bar may be misaligned
Zimmer Surgical is recalling 839 Zimmer Air Dermatomes because the devices may have a misaligned thickness control bar.
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 2/5 (Moderate).
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: Scored 2 because the record cites a misaligned control bar with no stated consequence or reported harm.
Plain-English summary
The Zimmer Air Dermatome, model 00880100100, from Zimmer Surgical Inc, is being recalled.
The reason given in the enforcement record is that the devices may have a misaligned thickness control bar.
The record lists 839 units, with lot and serial numbers listed in the enforcement record including lot 65944745 and serial number 115821 under UDI (01)00889024375901. Distribution covered the USA, Hong Kong, Thailand, Japan, Korea, Australia, Taiwan, India, Malaysia and Singapore among other regions. The FDA has classified the action as Class II.
The record describes a misaligned control component and states no consequence or reported injuries. Facilities should follow Zimmer's instructions.
The recalled product
- Product
- Zimmer Air Dermatome, Model/Catalog Number: 00880100100
- Manufacturer
- Zimmer Surgical Inc
- Affected units
- 839
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 (20)
- Lot Code: Model No 00880100100
- UDI (01)00889024375901(21)115821
- Lot Number 65944745
- Serial Number 115821
- Model No 00880100100
- UDI (01)00889024375901(21)115824
- Serial Number 115824
- UDI (01)00889024375901(21)115826
- Serial Number 115826
- UDI (01)00889024375901(21)115827
- Serial Number 115827
- UDI (01)00889024375901(21)115829
- Serial Number 115829
- UDI (01)00889024375901(21)115831
- Serial Number 115831
- UDI (01)00889024375901(21)115832
- Serial Number 115832
- UDI (01)00889024375901(21)115834
- Serial Number 115834
- UDI (01)00889024375901(21)115835
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Zimmer Surgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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