Recall Z-1679-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Electrosurgery
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 36 cm Shaft, Catalog Number 60-9522-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
| Date | May 29, 2012 (initiated May 7, 2012) |
| Status | Terminated |
| Reason | The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding. |
| Root cause | Process control |
| Action | ConMed Electrosurgery sent an "URGENT: DEVICE RECALL" letter dated May 2, 2012 to all affected customers. The letter identifies the product, problem,and actions to be taken by the customers. The letter instructs customers to review their inventory and to complete and return a Business Reply Form via fax to 303-699-9854. |
| Quantity | 153 units |
| Distribution | Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC, MD, CT, NJ, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101534 | CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM Conmedcorp, Nov 24, 2010 |