Updates on recall of Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee inserts labelled with 8-year shelf life

A Dear Healthcare Professional Letter has been issued by Exactech Pte Ltd, as a follow-up to their earlier communication in October 2021, to update healthcare professionals of Phase II of the recall of Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee inserts labelled with an 8-year shelf life. Following the completion of Phase 1 of the recall which involved UHMWPE knee inserts labeled with an 8-year shelf life with the expiry dates on or before 31 August 2025, Phase II of the recall will be initiated to remove all remaining UHMWPE knee inserts labeled with an 8-year shelf life regardless of shelf age. 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. The 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. Healthcare professionals are advised to not implant the affected devices and to return them to Exactech. 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: 21 Feb 2023

Dear Healthcare Professional Letters