Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/STRYKER RECIP, Catalog # 00505233400, 00505233200, 00505923500, 00507210100, 00507218100, and 00505331100. 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.

FDA Recall Z-0393-2009 · Posted 2009-01-15

Recalling FirmLinvatec Corp.
Recall StatusTerminated
Product CodeGET
Date Initiated2008-02-21
Date Terminated2009-01-15
Product Quantity3693

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.

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

Root Cause

Process control

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑