On April 10, 2013, Stryker Howmedica Osteonics Corporation initiated a Class I recall of their ShapeMatch Cutting Guides. The ShapeMatch Cutting Guides are single-use, disposable cutting guides intended to help a surgeon mark the bone before cutting during a total knee replacement surgery. The guides ultimately assist the surgeon in the positioning of the total knee replacement components. The ShapeMatch Cutting Guides were used in conjunction with the Stryker Triathlon Knee System. The cutting guides are manufactured for patients individually based on imaging studies of the patients’ knee such as an MRI or CT Scan. The ShapeMatch Cutting Guides were approved by the U.S. Food and Drug Administration (FDA) in May 2011 through the 510(k) approval process.
At some point, Stryker became aware of potential issues associated with the internal processes for planning cases and producing the ShapeMatch Cutting Guides. The parameters of the manufactured cutting guides did not meet the surgeons’ parameters. When the parameters were edited to correct the issue, the cutting guides were outside the range that is cleared by the FDA. As a result, in November 2012, Stryker emailed surgeons and imaging centers advising them to stop prescribing, planning or performing operative or imaging procedures with the ShapeMatch Cutting Guides until further notice. Subsequently, on April 10, 2013, Stryker issued an Urgent Medical Device Recall of the ShapeMatch Cutting Guides.
Due to the defect in the ShapeMatch Cutting Guides, patients may experience adverse health consequences including joint instability, fracture, the need for revision surgery and chronic pain and limitations with mobility. Stryker recommends that patients who are experiencing symptoms contact their surgeon for evaluation.
The FDA has classified the recall as a Class I event, the most serious type of recall since it may involve situations in which there is a reasonable probability that the use of these products will cause serious adverse health consequences or even death.
If you underwent a total knee replacement with the ShapeMatch Cutting Guide or Stryker Triathlon Knee System, please contact our firm at 1-800-247-1623 or firstname.lastname@example.org for a free consultation to discuss your legal rights.
Click here for frequently asked questions regarding the Stryker ShapeMatch Cutting Guide recall.
Click here to read the F.D.A.’s Stryker ShapeMatch recall notice.