ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-003. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
FDA Recall Z-0101-2007 · Posted 2006-10-27
Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeGCJ
Date Initiated2006-10-12
Date Terminated2012-08-30
Product Quantity970 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.