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Terminated

ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-435. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

FDA Recall Z-0110-2007 · Posted 2006-10-27

Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeGCJ
Date Initiated2006-10-12
Date Terminated2012-08-30
Product Quantity16 units

Reason for Recall

The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

Firm Action

On 10/12/06, ConMed sent "URGENT DEVICE RECALL" packages (letter dated 10/11/06) to the domestic accounts via UPS Ground, and via UPS Express for the International accounts. Devices are to be removed from use and returned.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943327CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTSConmedcorp · 1994-11-07

Official Source

View FDA Recall →

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

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