Recalls / —
—#82678
Product
BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures.
- FDA product code
- HTS — Knife, Orthopedic
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot Number: 7291713, Expiration Date: 2012-10.
Why it was recalled
Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.
Root cause (FDA determination)
Packaging process control
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson and Company
- Address
- 411 Waverley Oaks Rd, Ste 2229, Waltham, Massachusetts 02452-8448
Distribution
- Distribution pattern
- Worldwide Distribution -- United States, Japan and Belgium.
Timeline
- Recall initiated
- 2009-06-12
- Posted by FDA
- 2010-05-21
- Terminated
- 2012-01-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #82678. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.