Z-1566-2009

Smith & Nephew Endoscopic Disposable Blades: INCISOR BLADE,3.5MM DSPL,EP-1 Part #: 7205312. DYONICS Series...

Name: Z-1566-2009 Smith & Nephew Endoscopic Disposable Blades: INCISOR BLADE,3.5MM DSPL,EP-1 Part #: 7205312. DYONICS Series...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2009-05-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-05-07 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew Endoscopic Disposable Blades: INCISOR BLADE,3.5MM DSPL,EP-1 Part #: 7205312. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery... on 2009-05-07. The reason FDA records is "Product sterility is compromised due to breach in the sterile packaging". 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-1566-2009
Status: Terminated
Initiated: 2009-05-07
Posted: 2009-07-14
Terminated: 2012-05-08
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew Endoscopic Disposable Blades: INCISOR BLADE,3.5MM DSPL,EP-1 Part #: 7205312. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.
Product code: NBH Accessories, Arthroscopic
Reason for recall: Product sterility is compromised due to breach in the sterile packaging.
Root cause tag: packaging
FDA root cause: Pending
Action: Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655.
Quantity in commerce: 168 units
Distribution: Worldwide Distribution -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.
Product codes and lots: Lot #: 20153858.

Product code NBH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)