Medicamat Punch Hair Matic Recalled for Misbranded Marketing Literature
Medicamat is recalling 71 units of the Punch Hair Matic surgical hair transplant device due to misbranded marketing literature.
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: The recall is classified as FDA Class II and involves misbranded marketing literature, which aligns with the rubric criterion for minor labeling errors and voluntary precautionary recalls.
Plain-English summary
Medicamat S.A. is initiating a field correction for the Punch Hair Matic, a surgical hair transplant device designed for the automation of follicular transplantation. The recall involves 71 units distributed in the United States, including Texas, between October 16, 2012, and December 18, 2013.
The reason for the recall is misbranded marketing literature associated with the device. The source text does not report any illnesses, injuries, or deaths associated with this issue.
Consumers and healthcare providers with affected units should contact the recalling firm for instructions on the field correction. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
- Manufacturer
- MEDICAMAT S.A.
- Hazard
- Affected units
- 71
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)
- Serial numbers of units distributed from October 16
- 2012 to December 18
- 2013: 189
- 190
- 191
- 192
- 193
- 207
- 208
- 209
- 210
- 211
- 212
- 213
- 216
- 217
- 218
- 219
- 220
- 221
Distribution
Distributed in 1 state:
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