Urgent Medical Device Recall for Osseofix Sterile Package Implants, Size 4.5mm, 5.5mm and 7.0mm

Opto Systems (S) Pte Ltd (Opto Systems) would like to inform healthcare professionals of the urgent medical device recall conducted by the product owner, Alphatec Spine Corporation, for affected lots of Osseofix Sterile Package Implants, Size 4.5 mm, 5.5 mm and 7.0 mm. Opto Systems is issuing this letter, as some packaged sterile single-use units from affected lots of Osseofix Sterile Package Implant Sizes 4.5 mm, 5.5 mm and 7.0 mm may include subcomponent Osseofix Inserter Cannulas that may have been used by prior customer(s).  Used Osseofix Inserter Cannula may have bone cement residue present at time of attempted use, preventing intended use of the device.  If partially obstructed, cement particles could dislodge from the inserter and be introduced to the patient. Healthcare professionals are advised to 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.