Z-0397-2009

ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLADE, Catalog # 00502314400, 00502313900, 00502314100...

Name: Z-0397-2009 ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLADE, Catalog # 00502314400, 00502313900, 00502314100...
Creator: Linvatec Corp.
Published: 2008-02-21
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2008-02-21 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. began a recall of ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLADE, Catalog # 00502314400, 00502313900, 00502314100, 00502311800, 00502313800, 00502314000, and... on 2008-02-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0397-2009
Status: Terminated
Initiated: 2008-02-21
Posted: 2009-01-15
Terminated: 2009-01-15
Recalling firm: Linvatec Corporation
Product: ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLADE, Catalog # 00502314400, 00502313900, 00502314100, 00502311800, 00502313800, 00502314000, and 00502312800. 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.
Product code: GET Motor, Surgical Instrument, Pneumatic Powered
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.
Root cause tag: manufacturing process
FDA 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 Bill Number and the return goods number. Recall is being conducted to the distributor and end user level.
Quantity in commerce: 30403
Distribution: Worldwide Distribution
Product codes and lots: BBD23466, BBD29778, BBD29779, BBD31414, BBD31966, BBD34684, BBD23581, BBD26613, BBD28001, BBD29406, BBD31980, BBD21938, BBD23046 through BBD23050, BBD23828, BBD24448, BBD24633, BBD24634, BBD24635, BBD24636, BBD25062, BBD25063, BBD25066 through BBD25071, BBD25075, BBD25342 through BBD25344, BBD25448, BBD25345 through BBD25348, BBD28220, BBD28221, BBD29967 through BBD29971, BBD31755 through BBD31758, BBD32191, BBD33986 through BBD33989, BBD33991 through BBD33994, BBD33996, BBD33997, BBD34284, BBD34285, BBD35203, BBD35406, BBD35407, BBD35715, BBD36138, BBD36140, BBD36454, BBD36455, BBD36861, BBD36862 through BBD36864, BBD37677, BBD42014, BBD21968, BBD23826, BBD26026, BBD26276, BBD30509, BBD31759, BBD34787, BBD35411, BBD39000, BBD21955, BBD23038, BBD24444, BBD27210, BBD32799, BBD33034, BBD40973, BBD23464, BBD27209, BBD29395, BBD37661, BBD37683, BBD39764, BBD21966, BBD23039, BBD23825, BBD30501, BBD30503, BBD31752, BBD33985, BBD34279, BBD35200, BBD35713, BBD36137, BBD36458, and BBD40975.

Product code GET

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)