Recall Z-0953-2015— DePuy Orthopaedics, Inc.

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2014-11-10, terminated 2015-12-08. FDA's recall record names no specific 510(k) clearance for this event. Product: The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the purpose of impaction, extraction, and insertion applications at steps within the surgical procedure. Due to the frequency of its use, two impaction handles are supplied in each kit.. Reason: Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery..

Recalling firm

DePuy Orthopaedics, Inc.

Classification

Class II

Status

Terminated

Initiated

2014-11-10

Terminated

2015-12-08

Firm location

Warsaw, IN, United States

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