Reported Jun 25, 2014 · Terminated
Altrus Thermal Tissue Fusion Handpieces under the following specifications
ConMed Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConMed Corporation · 525 French Road · Utica, NY · 13502
Is this the product you have?
Altrus Thermal Tissue Fusion Handpieces under the following specifications
6 of 6 products
| Model / number | Product as published |
|---|---|
60-9510-001 | 10mm x 16 cm |
60-9511-001 | 10 mm x 23 cm |
60-9512-001 | 10 mm x 36 cm |
60-9520-001 | 5 mm x 16 cm |
60-9521-001 | 5 mm x 23 cm and |
60-9522-001. | 5 mm x 36 cm Products are packaged within cartons, 6 units per carton. |
- Lot codes and dates
- all lot codes
- Amount recalled
- 12,653 units (10,769 domestically & 1,884 internationally)
Why it was recalled
ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
This product could cause temporary or reversible health problems — stop using it.
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