ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Endoweave Multiple Use Grasper", 5 mm x 33 cm, REF/Product code 1-1028. -------- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
FDA Recall Z-1434-06 · Posted 2006-08-24
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Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-03-27
Date Terminated2012-04-27
Product Quantity3496 units
Reason for Recall
Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.
Firm Action
On 3/27/06, all domestic customers were sent an "URGENT DEVICE RECALL" notice, dated 3/27/06, by USPS Priority Mail (Delivery Confirmation). International customers were notified by facsimile and/or e-mail as well as by mail.
Root Cause
Other
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.
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