Stryker Shapematch Recall Issued for Knee Replacement Cutting Guide
Stryker Corporation has recalled cutting guides meant to help orthopedic surgeons conduct knee replacement surgeries following product complaints.
The FDA has determined that ShapeMatch Cutting Guides by Stryker have defects that could lead to severe injury for patient following a knee replacement, possibly even leading to death.
The ShapeMatch Cutting Guides recall is being designated as a Class I medical device recall, the most serious categorization.
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Stryker sent out a warning to surgeons who purchased the ShapeMatch guides in November, indicating that consumers should stop using them. In January, the company began pulling them from the market completely.
The recall came after the company realized that the guides may not have been manufactured correctly. The issues were discovered after receiving product complaints and conducting post-marketing surveillance.
The ShapeMatch Cutting Guides are cut specifically for each patient and used to assist in positioning of total knee replacement components. They also guide the marking of bone before the orthopedic surgeon begins cutting.
Stryker warns that using the cutting guides could result in a knee not functioning properly. The company states that patients who have undergone surgery with the ShapeMatch guides and are experiencing no knee problems do not need to take any action. However, patients experiencing difficulties with their knee implant should see their orthopedic surgeon. Patients can also contact Stryker by calling 1-888-STRYKER.
The Class I recall comes about one month after the FDA issued a warning letter to Stryker over quality control issues at its Portage, Michigan facility. The letter cites the company for failing to notify the FDA of a medical device recall, but does not name the device that was recalled. It is not clear if the letter is referring to ShapeMatch Cutting Guides.
DIANAApril 15, 2013 at 2:19 pm
ShapeMatch was originally Otis Med Custom Cutting Guides. Otis Med was purchased by Stryker and re-named the cutting guides ShapeMatch. The public should know about the double name of these cutting guides. There are a lot of people out there still suffering, for years, with pain and instability after a TKR in which Otis Med custom cutting guides were utilized. Thank you
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