Voluntary medical device recall of PFNA and PFNA-II Femoral Nails and PFNA-II Endcaps (R2014081)
Healthcare professional
Medical devices
1 April 2015
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Johnson & Johnson Pte Ltd (‘J&J’) would like to inform healthcare professionals of a voluntary recall of specific part and lot numbers of its Proximal Femoral Nail Antirotation (PFNA) and PFNA-II Femoral Nails and PFNA-II Endcaps. J&J is initiating this recall, as the affected 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 J&J. 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.
