How does the recall affect me if I have a DePuy LPS Diaphyseal Sleeve implanted in my leg?
Technically, the DePuy LPS Diaphyseal Sleeve recall, as issued by DePuy Orthopaedics, Inc., and the FDA’s Class I recall do not affect sleeves already implanted in patients.
The order calls for hospitals and surgeons to immediately stop distributing or using the recalled devices and to return any they have in stock to DePuy. The manufacturer is not recommending revision surgery or any additional follow-up with patients who have already received the sleeve in the absence of symptoms that the device has failed. According to the FDA, DePuy is “encouraging surgeons to communicate with patients” about the problems with the DePuy LPS Diaphyseal Sleeve and to instruct patients on how to recognize problems if they occur.