Smith & Nephew Endoscopic Disposable Blades: INCISOR, 5.5mm,EP-1,DSPL BLADE Product #: 7205314. DYONICS Series 3000 BONE

FDA device recall Z-1563-2009 · posted 2009-07-14 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc. Endoscopy Division

Reason for recall

Product sterility is compromised due to breach in the sterile packaging.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

NBH

Quantity affected

342 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 an

Date initiated

2009-05-07

Date posted

2009-07-14

Date terminated

2012-05-08

Location

Andover, MA