FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0363-2009
- Recalling firm
- Linvatec Corp.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-02-21
- Posted
- 2009-01-15
- Terminated
- 2009-01-15
- 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 Bill Number and the return goods number. Recall is being conducted to the distributor and end user level.
- Quantity
- 1494
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- BBD26850, BBD28017, BBD32424, BBD23256, BBD26619, BBD26860, BBD27088, BBD29760, BBD31407, BBD33236, BBD35916, BBD37134, BBD38304, BBD23266, BBD26288, BBD28115, BBD29767, BBD31979, BBD34452, BBD31983, BBD34448, 00990108, BBD42853, BBD38043, BBD23255, BBD24400, BBD26625, BBD27087, BBD28010, BBD30518, BBD31974, BBD36888, and BBD38292.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GET
- Firm FEI
- 1017294
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28