Recall Z-1457-2014— Synthes, Inc.

Name: FDA recall Z-1457-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-11

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2014-02-11, terminated 2015-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.. Reason: The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-11
Terminated: 2015-09-10
Firm location: West Chester, PA, United States

Product description

The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.

Reason for recall

The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.

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