Dermatome AN units recalled because the thickness control bar may be misaligned
Zimmer Surgical is recalling 498 Zimmer Dermatome AN units because the devices may have a misaligned thickness control bar.
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: Scored 2 because the record cites a misaligned control bar with no stated consequence or reported harm.
Plain-English summary
The Zimmer Dermatome AN, model 88710100, 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 498 units, with lot and serial numbers listed in the enforcement record including lot 65900465 and serial number 701341. 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 Dermatome AN, Model/Catalog Number: 88710100
- Manufacturer
- Zimmer Surgical Inc
- Hazard
- misalignment
- thickness-control
- surgical-instrument
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 88710100
- UDI 00889024464834701341
- Lot Number 65900465
- Serial Number 701341
- Model No 88710100
- UDI 00889024464834701343
- Serial Number 701343
- UDI 00889024464834701344
- Serial Number 701344
- UDI 00889024464834701345
- Serial Number 701345
- UDI 00889024464834701346
- Serial Number 701346
- UDI 00889024464834701350
- Serial Number 701350
- UDI 00889024464834701351
- Serial Number 701351
- UDI 00889024464834701352
- Serial Number 701352
- UDI 00889024464834701353
Distribution
Distribution scope not specified by the agency.
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