Category: Device 483s
Inspection date range: 3/21/12-4/2/12
Company: Genesys Orthopedic Systems, LLC
1250 S. Capital of Texas Hwy #600
Austin, TX 78746-6446
Inspector(s): Iris C. Maciness
Observations: An MDR was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.