Recall Z-2087-2014— Synthes, Inc.

Name: FDA recall Z-2087-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-29

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2014-05-29, terminated 2016-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.. Reason: The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Terminated: 2016-08-18
Firm location: West Chester, PA, United States

Product description

Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.

Reason for recall

The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.

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