Recall Z-1914-2017— Smith & Nephew, Inc.

Name: FDA recall Z-1914-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-30

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-03-30, terminated 2019-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1). Reason: The stability data does not support the product labeled with a 10-year shelf life..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-30
Terminated: 2019-08-21
Firm location: Memphis, TN, United States

Product description

RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Data sourced from openFDA. This site is unofficial and independent of the FDA.