This chart lists medical device-related close-out letters released by FDA in June 2016. FDA’s close-out program publicly indicates when a manufacturer has addressed agency concerns outlined in a warning letter.

ACell Inc.(MatriStem Surgical Matrix Thick)

Close-out letter date: June 1, 2016 • Original warning letter date: April 23, 2013

Closed-out violations: QS/MDR • [Issued by Baltimore District Office]

Advanced Sterilization Products(Various STERRAD products)

Close-out letter date: June 2, 2016 • Original warning letter date: March 12, 2010

Closed-out violations: QS/Premarket • [Issued by Los Angeles District Office]

Medsource Inc. (Orthopedic surgical instrument trays)

Close-out letter date: May 17, 2016 • Original warning letter date: Sept. 24, 2015

Closed-out violation: QS • [Issued by New England District Office]

MicroAire Surgical Instruments LLC(Endotine and Ultratine biodegradable implants)

Close-out letter date: June 13, 2016 • Original warning letterdate: Dec. 29, 2014

Closed-out violations: QS/MDR • [Issued by Baltimore District Office]

Warning Letter Close-Outs – June 2016

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