Z-0067-2010

Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO...

Name: Z-0067-2010 Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2009-07-31
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2009-07-31 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO. 5.141.517. The Arthro-Knife is a one piece disposable... on 2009-07-31. The reason FDA records is "ConMed has determined there is a possibility that the device may not fully retract once it is deployed". 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-0067-2010
Status: Terminated
Initiated: 2009-07-31
Posted: 2009-10-21
Terminated: 2011-02-25
Recalling firm: Linvatec Corporation
Product: Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO. 5.141.517. The Arthro-Knife is a one piece disposable assembly comprised of a plastic handle with a retractable blade, sheathed blade. These knives are supplied sterile, single-use. Each knife assembly contains a color coded sliding retractor that coincides with a specific blade type. The blade can be extended and locked to a half extended position or fully extended position.
Product code: HST Apparatus, Traction, Non-Powered
Reason for recall: ConMed has determined there is a possibility that the device may not fully retract once it is deployed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ConvaMed Linvatec USA issued an "Urgent Medical Device Recall" notification via Fed Ex to all direct consignees of the affected product. Users were asked to inventory and return all affected product to the firm and to return a reply form by mail or fax. For further information, contact customer service at 1-800-237-0169 for US or your local ConMed Linvatec office for outside US or email at [email protected].
Quantity in commerce: Approximately 66,144 products.
Distribution: Worldwide Distribution
Product codes and lots: All product with the following Catalog Numbers: 70-0071-103 ANTHRO-KNIFE BANANA STR 6EA; 70-0078-103 ARTHRO-KNIFE 2 SIDE RND S 6 EA; 70-0071-113 ARTHRO-KNIFE BANANA LEFT 6 EA; 70-0074-103 ARTHRO KNIFE ROSETTE STR 6 EA; 70-0076-003 ARTHRO KNIFE CRESENT STR 6 EA; 70-0077-103 ARTHRO-KNIFE 2-SIDE POINT 6 EA; 70-0072-003 ARTHRO-KNIFE HOOK STR 6 EA; 70-0073-003 ARTHRO-KNIFE RETRO STR 6 EA; 70-0075-003 ARTHRO-KNIFE MINI MENISCU 6 EA.

Product code HST

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)