Voluntary recall for PFNA, PFNA-II, DFN & PFN Nails, PFNA & PFNA-II Blades, and PFNA & PFNA-II End Cap Extensions
Healthcare professional
Medical devices
25 January 2016
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Johnson & Johnson Pte Ltd would like to notify healthcare professionals on the recall of selected parts and lots of Proximal Femoral Nail Antirotation (PFNA) Nails, PFNA-II Nails, Distal Femoral Nails (DFN), Proximal Femoral Nails (PFN), PFNA Blades, PFNA-II Blades, PFNA End Cap Extensions and PFNA-II End Cap Extensions. The product owner, Synthes GmbH, is initiating this recall as the identified implants may have incorrect anodized colour coding. An implant with an incorrect anodized colour coding would not cause harm to the patient. If the user identifies the nonconformity during surgery, marginal surgical delay may occur while an alternate implant is located. Healthcare professionals are advised to return the affected implants to Johnson & Johnson and to conduct routine post-operative follow-ups with their patients as per normal guidance. 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.
