The Food and Drug Administration has issued Lucero Medical a letter of warning related to its spinal fusion device Enduramesh.
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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The Enduramesh product cited is different from the Enduramesh Model 762.XXX, which was cleared by the FDA in April 2010.
More Articles on Spinal Devices:
15 New Spine Devices & Systems to Know
Expanding Orthopedics Receives Patent for Spine Device
Medtronic Pays $85M Settlement in Infuse Lawsuit