Recall Z-0585-2016— Synthes (USA) Products LLC

Name: FDA recall Z-0585-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-01

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-12-01, terminated 2016-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.. Reason: The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-12-01
Terminated: 2016-08-26
Firm location: West Chester, PA, United States

Product description

SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.

Reason for recall

The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.

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