Thankfully hip replacement recalls happen fairly infrequently but a recall certainly has the potential to cause a lot of alarm, distress and worry for patients, families and orthopaedic surgeons.
The purpose of this page is to provide an overview of the main requirements that regulators set out for the management and communication of replacement hip recalls.
Many of the basic principles and steps for a recall are similar for most regulated medical devices, But for the purposes of this page I will use hip replacement recalls as a worked example.
Depending on the country and the specific nature of the product involved the mandatory steps can be more or less onerous for the manufacturers and or distributors of the recalled product.
Recall processes vary from one country to another so it is important that you identify the specific requirements that apply to your country.
Replacement hip recalls are undertaken to either:
Regulators around the World issue detailed, country specific directives and guidelines that set out the minimum standards and recommended actions whenever medical products are recalled. The overriding objective is to achieve effective and efficient coordination between manufacturers, distributors and regulators whenever a product recall is undertaken.
The majority of replacement hip recalls are initiated voluntarily by manufacturers or distributors. However, in most countries, regulators do have powers to instruct a mandatory recall regardless of the position taken by the product manufacturer or distributor.
For example, a manufacturer might initiate a voluntary hip replacement recall if emerging evidence suggests that the hip implant is not performing as was originally expected. Such a recall would not necessarily suggest the product is faulty, merely that, as a precautionary measure, the manufacturer is taking a proactive step to remove a product where there is the possibility that the product may put a patient's health risk
In contrast, it may be that there is a compelling body of evidence of actual injury to recipients of a particular type of hip implant, compiled and evaluated by orthopaedic surgeons and other specialists in one particular country or region that prompts a voluntary product recall.
A mandatory recall would typically take place where credible & compelling evidence of unexpected risk of harm, or actual harm, is presented to the regulator, but for whatever reason the manufacturer or distributor refuses to, or has not yet, initiated a voluntary recall.
The hip replacement recall process is typically very detailed and very prescriptive, requiring the manufacturer or distributor to execute and manage the recall in a very particular fashion.
Prescribed steps may include:
In some countries and for some products, despite the prescriptive nature of the directives, it is possible for manufacturers or distributors to adopt alternative approaches to the management of product recalls as long as the approach satisfies the minimum statutory and regulatory requirements.
Hip replacement recalls are relatively few in number when set in the context of the millions of hip replacement implants that are used annually around the World.
However, no one should underestimate the profound impact that any one instance of product recall will have on many thousands of individuals, certainly in terms of anxiety and possibly in terms of personal injury sustained.