Recall for TANDEM™ Bipolar Hip System due to an out of specification retainer groove

Smith & Nephew Pte Ltd would like to notify healthcare professionals of the recall for selected models of the TANDEM™ Bipolar Hip System. The recall is initiated following complaints and Smith & Nephew’s Health Hazard Evaluation which showed that a subset of Bipolar shells were manufactured with an out-of-specification retainer groove. Affected devices have a higher risk of failures that includes poor assembly intra-operatively, or appearing to assemble properly intra-operatively but dissociates post-operatively. Smith & Nephew assessed that the device is likely to perform without incident for cases where the devices may have appeared to be assembled properly. Healthcare professionals are advised to maintain their routine follow-up protocol for patients who have been implanted with the affected devices. Please refer to letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.