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Terminated

Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32

FDA Recall Z-0613-2007 · Posted 2007-03-13

Recalling FirmGyrus ACMI Corporation
Recall StatusTerminated
Product CodeKNS
Date Initiated2007-02-19
Date Terminated2008-02-24
Product Quantity527 boxes (5 units/box)

Reason for Recall

Product sterility may be compromised due to failure of the tray seal packaging

Firm Action

Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product .

Root Cause

Packaging process control

Distribution Pattern

Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932293CABOT MEDICAL BIPOLAR CUTTING FORCEPSCabot Medical Corp. · 1994-07-27

Official Source

View FDA Recall →

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

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