Recall Z-1638-2010 ยท HTS Knife, Orthopedic
Becton Dickinson and Company
BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures.
| Date | May 21, 2010 (initiated Jun 12, 2009) |
| Status | Terminated |
| Reason | Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 354 units |
| Distribution | Worldwide Distribution -- United States, Japan and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.