Recall Z-0332-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Corporation
ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed 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. The Altrus
| Date | Nov 15, 2013 (initiated Oct 23, 2013) |
| Status | Terminated |
| Reason | The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection. |
| Root cause | Material/Component Contamination |
| Action | The firm, ConMed, sent an "URGENT: VOLUNTARY DEVICE RECALL" letter dated October 23, 2013 and Business Reply Forms to the domestic consignees/customers via USPS Priority Mail. Distribution of the recall letter to the foreign consignees will follow once the letter has been translated into the different foreign languages. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop the use of these devices; review your inventory for any of the devices listed; contact all of those organizations within your facility and any other facilitie |
| Quantity | 147 handpieces (Domestic: 135 devices; Foreign: 12 devices) |
| Distribution | Worldwide distribution: US (Nationwide) and countries of: Canada, Germany and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101534 | CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM Conmedcorp, Nov 24, 2010 |