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Terminated

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.

FDA Recall Z-0067-2010 · Posted 2009-10-21

Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeHST
Date Initiated2009-07-31
Date Terminated2011-02-25
Product QuantityApproximately 66,144 products.

Reason for Recall

ConMed has determined there is a possibility that the device may not fully retract once it is deployed.

Firm 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].

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.

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