Recall of specific lots of MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging
Healthcare professional
Industry member
Medical devices
6 April 2021
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A Dear Healthcare Professional Letter has been issued by Johnson & Johnson Pte Ltd to inform healthcare professionals of the recall of specific lots of MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging which could result in sterility breach or residual packaging materials on the tibial implants. Implantation of potentially contaminated product could lead to infection and pain. If the presence of polyurethane residue is not detected intraoperatively, and is left in the patient, this may potentially impair the range of motion in a rotating platform construct or cause an inflammatory reaction. Healthcare professionals are advised to immediately quarantine all the affected devices. For patients previously implanted with affected devices, healthcare professionals are advised to continue to follow up on them post-operatively according to the physician’s standard of care. Please refer to the 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.
