Z-1638-2010

BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454...

Name: Z-1638-2010 BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454...
Creator: Becton Dickinson and Company
Published: 2009-06-12
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2009-06-12 / Terminated / root cause: packaging

FDA source

Becton Dickinson and Company began a recall of BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures on 2009-06-12. The reason FDA records is "Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1638-2010
Status: Terminated
Initiated: 2009-06-12
Posted: 2010-05-21
Terminated: 2012-01-26
Recalling firm: Becton Dickinson & Co
Product: BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures.
Product code: HTS Knife, Orthopedic
Reason for recall: Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.
Root cause tag: packaging
FDA 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 in commerce: 354 units
Distribution: Worldwide Distribution -- United States, Japan and Belgium.
Product codes and lots: Lot Number: 7291713, Expiration Date: 2012-10.

Product code HTS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)