DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall
MedSun: Newsletter #82, March 2013

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I recall of the LPS Diaphyseal Sleeve. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.

Additional Information:

DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall. February 22, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340740.htm


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