Device product
Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.
Z-1839-2014
Product summary
- Event
- Event 67610
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,653 units (10,769 domestically & 1,884 internationally)
- Official record key
device-enforcement:Z-1839-2014
Official wording
Reason: ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
Code information: all lot codes
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.