Recall of Exactech Ultra-High Molecular Weight Polyethylene Knee Inserts with an 8-year shelf life

A Dear Healthcare Professional Letter has been issued by Exactech Pte Ltd to inform healthcare professionals of the recall of Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee inserts labelled with an 8-year shelf life. These inserts were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH) as specified on the packaging drawing. Use of vacuum bags without an EVOH layer may result in elevated transmission of oxygen to the UHMWPE knee insert packaged therein which can potentially result in increased oxidation of the material relative to inserts packaged with EVOH over time. Exposure to oxygen over time can allow oxidation of the UHMWPE implant leading to a reduction of mechanical properties, which may ultimately require revision of the implant (UHMWPE Component). However, Exactech’s testing and risk assessment confirmed that the Nylon bags without the EVOH oxygen barrier properties performed similarly to Nylon bags with the EVOH oxygen barrier through 5 years of shelf life. Healthcare professionals are advised not to implant Exactech Knee Insert with labelled expiry date before 31 August 2025 and to return them to Exactech immediately. Healthcare professionals are also advised to conduct a routine clinical exam and a routine set of knee x-rays to identify premature polyethylene wear (standing AP, lateral, and sunrise views) on patients who have been implanted with the affected devices, and who have not been seen in over 12 months. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices

Dear Healthcare Professional Letters

25 Oct 2021

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.