Recall Z-0363-2009 ยท GET Motor, Surgical Instrument, Pneumatic Powered
Linvatec Corp.
ConMed Linvatec Hall Surgical Blades, Sterile LG BONE OSC BLADE, Catalog #00507154800, 00507154700, 00507123600, 00507155700, 00507155800, 00507159000, and 00507157100. ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
| Date | Jan 15, 2009 (initiated Feb 21, 2008) |
| Status | Terminated |
| Reason | Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. |
| Root cause | Process control |
| Action | An Urgent Medical Device Recall letter was issued. Customers must check their facility's inventory immediately for the catalog and lot numbers in the attached list. They also need to complete and sign the enclosed Reply Form and mail or fax the Reply Form to ConMed Linvatec using the enclosed self addressed postage paid envelope or fax 727-319-5701. Customers have an option to either re-sterilize the products using the re-sterilization instructions in the letter or they can return the devices to ConMed Linvatec for a credit using the enclosed preprinted FedEx Air Bill with ConMed Linvatec's |
| Quantity | 1494 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.