The Exactech Knee Recall: What It Means If Your Knee Replacement Is Failing

Medical device guides · 14 min read · Published 10 November 2026 · Reviewed 10 November 2026 · Next review May 2027

By Dr Rosemary Listing, PhD (Law) · Medical negligence lawyer since 2014 · Of Counsel, Peter Evans & Associates

If you have an Exactech knee and it is causing problems, or you are not sure whether you have one, I want you to know that your questions are reasonable. A recall is not your fault, and you are entitled to know what is inside your own body.

This guide covers what the recall was about, how to find out your implant details, what follow-up was recommended, what your records should show, and how the law looks at it.

Start with your question

• What was the Exactech knee recall?
• How do I know if I have an Exactech knee?
• What follow-up was recommended?
• What are signs of a failing knee replacement?
• What is a revision knee replacement?
• Is it a device claim or a care claim?
• Could this be medical negligence?

How a knee replacement works

A total knee replacement resurfaces the worn ends of the bones. A metal part covers the end of the thigh bone, a metal tray sits on the shin bone, and a plastic insert between them acts as the smooth bearing surface.

What the recall was about

The recall, which began in Australia on 3 November 2021, covers ultra-high molecular weight polyethylene (UHMWPE) knee inserts labelled with an 8-year shelf life.¹ Exactech found that most inserts made since 2008 had been packed in vacuum bags that were out of specification: they lacked a secondary oxygen barrier layer. More oxygen could reach the plastic, increasing oxidation. For inserts that had spent more than five years on the shelf before surgery, that could lead to premature wear that may require revision surgery.¹

Finding out if you are affected

Your hospital records should include the implant sticker from your operation, showing the brand, product and lot number. Ask the hospital or your surgeon for the implant record. Not every Exactech knee is affected; it depends on the insert and its packaging.¹ Our guide to getting your medical records explains how to ask.

The follow-up that was recommended

The recall notice advised surgeons that patients with affected inserts that were more than five years old when implanted, and who had not been seen in over 12 months, should be brought in for a clinical examination and knee X-rays. If abnormal wear was found, revision of the insert could be considered.¹

Questions to ask your surgeon

• What brand and model of knee do I have, and is my insert affected?
• When was I last reviewed, and were X-rays taken?
• Is there any sign of wear or loosening?
• What would revision involve for me?

Signs a knee replacement may be failing

Wear and loosening are among the reasons a knee replacement may need to be revised.² Symptoms can come on gradually: pain that returns after years of comfort, swelling, a feeling the knee is unstable or giving way, clicking or clunking, or reduced movement.

Expected, worth a review, or emergency

Revision surgery

A revision replaces some or all of the parts of a knee replacement. It is generally a bigger operation than the first. healthdirect lists risks including damage to nerves, blood vessels or ligaments, the bone splitting, infection, loosening, and ongoing pain or stiffness that may be permanent.²

Device claim or care claim?

When a recalled device fails, there may be two separate questions. One is about the product itself, which is a claim against the manufacturer or supplier. The other is about care: whether your surgeon or hospital followed up as they should once the recall was known, and whether your symptoms were properly investigated. This guide focuses on the second. Our medication, drug and device harm page explains the difference.

What to look for in the records

Your records are often where the story becomes clear. You have a right to access your own health information. In NSW the Health Records and Information Privacy Act 2002 covers both public and private providers, and the Information and Privacy Commission explains how to ask.³ Our step-by-step guide to getting your medical records in Australia walks you through it.

How the law looks at it

A recalled implant wearing out is not automatically negligence by your surgeon. The surgeon may not have known about the packaging problem at the time of your operation. The legal questions are about what happened after: whether the follow-up and the response to your symptoms met the standard expected, and whether any shortfall caused harm.

A claim usually turns on three questions: whether the care fell below what peers would widely accept as competent practice (section 5O of the Civil Liability Act 2002 (NSW))⁴, whether that shortfall probably caused harm you wouldn't otherwise have had (Tabet v Gett)⁵, and, where it matters, whether you were told the material risks first (Rogers v Whitaker)⁶⁷. Our guide to how a medical negligence claim works explains each one in plain terms.

In an Exactech case, the questions might be: once the recall was issued, were reasonable steps taken to identify and contact you? Were you reviewed with an examination and X-rays as recommended? When you reported symptoms, were they investigated, or put down to normal ageing? Was wear acted on promptly?

In plain terms, the question is whether earlier review would probably have found the wear sooner, so that a smaller operation could have been done before damage to the bone.

For revision surgery, that would usually include the risks of the bigger operation and the expected recovery.

Who can claim, and when

The person with the knee replacement can claim. In NSW, time usually runs from when you knew, or ought to have known, enough to claim, not from the treatment itself, and courts can sometimes extend it, so an old injury may still count. See time limits in NSW or other states, and ask early.

More: complaint or claim? · how a claim is paid for · what a claim can cover

In my practice

In recall files, I often find that the problem is not the first operation but the follow-up. A letter is sent to an old address, or a review is booked and never chased. Meanwhile the person’s pain is put down to age. Reading the recall correspondence in the file often helps people understand exactly where the chain broke.

Both things can be true

Your surgeon may have done a good first operation with no way of knowing about the packaging problem, and the follow-up may still have fallen short. Both can be true.

The bigger picture

Recalls of medical devices in Australia are overseen by the Therapeutic Goods Administration. You can check your surgeon’s registration on the Ahpra public register,⁸ and complaints about care in NSW can go to the Health Care Complaints Commission.⁹

See also our guides to pacemaker failure and spinal fusion hardware failure.

Support

You don't have to work through this alone. These services can help:

• Lifeline, 24-hour crisis support: 13 11 14 (listed on healthdirect's helplines page)¹⁰
• Beyond Blue, anxiety and depression support: 1300 22 4636
• Medicare Mental Health, help finding mental health support: 1800 595 212
• healthdirect, 24-hour nurse advice: 1800 022 222
• Health Care Complaints Commission (NSW): 1800 043 159

A woman holding a letter that never reached her now knows where the chain broke. You deserve that clarity too.

With care,
Rosemary

Frequently asked questions