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. Published: 20 Oct 2021

Dear Healthcare Professional Letters