The letter warned the company about documentation and quality control issues related to Enduramesh, naming eight violations at its Hinckley, Ohio, facility. The FDA also issued a recall of the device in February.
The Enduramesh product cited is different from the Enduramesh Model 762.XXX, which was cleared by the FDA in April 2010.
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FDA Sends Warning Letter to Lucero Medical on Spinal Fusion DeviceWritten by Laura Miller | April 05, 2012
The Food and Drug Administration has issued Lucero Medical a letter of warning related to its spinal fusion device Enduramesh.
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