Recall Z-0067-2010 ยท HST Apparatus, Traction, Non-Powered
Linvatec Corp. dba ConMed Linvatec
Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO. 5.141.517. The Arthro-Knife is a one piece disposable assembly comprised of a plastic handle with a retractable blade, sheathed blade. These knives are supplied sterile, single-use. Each knife assembly contains a color coded sliding retractor that coincides with a specific blade type. The blade
| Date | Oct 21, 2009 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | ConMed has determined there is a possibility that the device may not fully retract once it is deployed. |
| Root cause | Process control |
| Action | ConvaMed Linvatec USA issued an "Urgent Medical Device Recall" notification via Fed Ex to all direct consignees of the affected product. Users were asked to inventory and return all affected product to the firm and to return a reply form by mail or fax. For further information, contact customer service at 1-800-237-0169 for US or your local ConMed Linvatec office for outside US or email at Custserv1@linvatec.com. |
| Quantity | Approximately 66,144 products. |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.