Recall Z-1839-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Corporation
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 c
| Date | Jun 20, 2014 (initiated Feb 20, 2014) |
| Status | Terminated |
| Reason | ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns. |
| Root cause | Device Design |
| Action | On February 20, 2014 and February 28, 2014 ConMed Corporation distributed Urgent Medical Device Correction notices to their domestic and foreign customers via FedEx Priority. The notice was generated by ConMed for information purposes only. Customers are to ensure that the jaws of the energy vessel sealing device does not come in contact with unintended tissue, surfaces, or objects until the jaws have cooled sufficiently. Customers who have further distributed this product, please forward a copy of the correction notice to the recipient as appropriate. Customers will questions should conta |
| Quantity | 12,653 units (10,769 domestically & 1,884 internationally) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101534 | CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM Conmedcorp, Nov 24, 2010 |