Stryker Receives FDA Warning Letter Lawsuit Result Of Recall

Stryker Corporation has received its third FDA warning letter in the past year. The medical device company received the latest warning letter due to “quality systems and compliance issues”. The letter noted issues with the plant’s handling of compliance issues with a past clinical study including medical device reporting procedures as well as the documentation used to approve medical implants.
The two previous warning letters concerned similar issues at Stryker plants in Mahwah New Jersey and Cork Ireland. Those letters prompted a recall of the Stryker hip implant due to manufacturing problems as well as defective design. The company is facing lawsuits associated with the recalled artificial hips.
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