ConMed Linvatec Hall Surgical Blades, Sterile ST OSC ABRASION BLADE, Catalog # 00507117500, 00507114100, 00507116700, 00

FDA device recall Z-0383-2009 · posted 2009-01-15 · Terminated

Recall details

Recalling firm

Linvatec Corp.

Reason for recall

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.

Action taken

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 Bill Number and the return goods number. Recall is being conducted to the distributor and end user level.

Root cause

Process control

Status

Terminated

Product code

GET

Quantity affected

5853

Distribution

Worldwide Distribution

Date initiated

2008-02-21

Date posted

2009-01-15

Date terminated

2009-01-15

Location

Largo, FL