As you may recall, in July 2021, Exactech issued an urgent worldwide recall regarding its Connexion GXL hip implant due to the inserts being stored in “non-conforming” vacuum bags. As stated in the recall letter – in Exactech’s own words – the consequence of the defective bags is there is:
Increased oxygen diffusion to the polyethylene insert resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer. Over time, oxidation can severely degrade the mechanical properties of the Connexion GXL polyethylene, which, in conjunction with other surgical factors, can lead to both accelerated wear and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.
For a free legal consultation, call,
In other words, to put it simply, the issue with Exactech’s storage bags is that they allow in oxygen. While oxygen is necessary for living beings, it is NOT something you want to infiltrate a device implant. Allowing that to happen can lead to the premature breakdown and failure of the implant due to a process called oxidation.
Exactech Expands Its Hip Recall in August 2022
Most recently, on August 11, 2022, Exactech issued yet another recall, this time expanding its hip recall to include seven additional hip liners. Specifically, the recall extends to the following devices:
|Product Family||US Clearance Date||Affected Devices Distributed in US|
|Acumatch GXL||September 2005||4422|
|MCS GXL||September 2005||238|
|Novation GXL||March 2007||33,654|
|Exactech All Polyethylene Cemented Cup||September 1996||37|
|Acumatch Conventional UHMWPE||November 1993||1,224|
|MCS Conventional UHMWPE||October 1993||28|
|NOVATION Conventional UHMWPE||July 2007||502|
As with the July 2021 recall, the August 2022 recall stems from more devices being stored in non-confirming vacuum bags. Accordingly, in this most recent recall letter, Exactech admitted, “Like the Connexion GXL, these liners are susceptible to increased oxygen diffusion during shelf storage, with subsequent risks for component fatigue and damage after implantation.”
What Should You Do If You Have a Recalled Exactech Product?
If you or a loved one have a recalled Exactech hip liner implant, Exactech has advised doctors to monitor the implant closely for signs of device failure. Device failure can sometimes lead to revision surgery where the device is required to be surgically removed and replaced.
Signs of product failure to look out for include but are not limited to:
- Limited mobility/range of motion
- Weakening or loosening of the joint
- Difficulty walking
- Inability to bear weight on the joint
- Griding nose in the joint
We will keep you updated as developments in the Exactech litigation arise.