ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
FDA Recall Z-0103-2007 · Posted 2006-10-27
Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeGCJ
Date Initiated2006-10-12
Date Terminated2012-08-30
Product Quantity38 units
Reason for Recall
The company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When the grasper jaws had broken they had done so at the junction of the jaw and the tube. In no instances was it reported to the company that small pieces had broken off of the grasper jaws.
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.