Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ConMed DetachaTip Laparoscopic Instrument: Fenestrated (Duckbill) Multiple Use Grasper, 5mm x 43cm, REF/Product Code 1-4307. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

FDA Recall Z-0090-2007 · Posted 2006-10-27

Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-10-12
Date Terminated2012-08-30
Product Quantity508 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.

K924283MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTSMicrosurge, Inc. · 1993-04-07

Official Source

View FDA Recall →

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

↑