Specific Lot Number Identified To Have Sleeve Issue

DePuy Orthopaedics has launched a voluntary recall of a lot of its BIOLOX Delta TS Ceramic Femoral Articul/eze 12/14 36mm +12 Heads after a fault was identified.

The company has issued a field safety notice revealing that some of its devices have an incorrect sleeve assembled to the device, with a smaller sleeve being used which led to a femoral head offset discrepancy.

It has been confirmed that the affected products have a code of 136536740 and a lot number of 7928614, with investigations confirming that this is the only lot affected by the recall.

DePuy has confirmed that this recall is intended to remove the affected devices and inform hospitals and surgeons of the possible consequences of using the device.

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Expert Opinion

News of another issue related to products manufactured by DePuy is a major concern, particularly as it comes following the major recall which was launched regarding the ASR Hip Resurfacing System and ASR XL Acetabular System due to failure rates. <br/> <br/>"While it is only related to a specific lot number of devices, the risks posed by such products cannot be underestimated and it is vital every possible step is taken to protect patients. Offset discrepancy in this way can affect a patient’s leg length post-surgery. <br/> <br/>"Too many patients have suffered injury or illness as a result of defective product issues which could and should have been avoided, and it is vital that everything possible is done to ensure lessons are learned from these specific problems."