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Terminated

BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures.

FDA Recall Z-1638-2010 · Posted 2010-05-21

Recalling FirmBecton Dickinson and Company
Recall StatusTerminated
Product CodeHTS
Date Initiated2009-06-12
Date Terminated2012-01-26
Product Quantity354 units

Reason for Recall

Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.

Firm Action

Becton Dickinson issued an "Urgent: Field Safety Notice" beginning June 25, 2009 by telephone and letter fax to remove and discard affected product from their possession. Customer verification responses were requested. For further information, contact Becton Dickinson and Company at 1-781-906-7900.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution -- United States, Japan and Belgium.

Official Source

View FDA Recall →

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

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