Voluntary Recall of Synthes 3.7mm and 5.0mm Dynamic Locking Screws (DLS)

Synthes Singapore Pte Ltd is voluntarily recalling all lots of Synthes 3.7mm and 5.0mm Dynamic Locking Screws (DLS). Synthes GmbH received product complaints that identified DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. Although there have been no reports of permanent impairment associated as a result of this product issue, the breakage of the Synthes 3.7mm and 5.0mm DLS could result in significant elongation of surgical time in planned implant removal. Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) is intended for the fixation of metaphyseal and diaphyseal shaft fractures of long bones (humerus, femur and tibia). The DLS allows micro-motion within the angular stable system. Please refer to the letter for more 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.