Recall Z-1396-2015— Bacterin International, Inc.

Class II FDA medical device recall by Bacterin International, Inc., initiated 2015-03-09, terminated 2015-07-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.. Reason: Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU and on the lid of the kits. Sterilization parameters for the Steam Gravity 121 degree C (250 F) cycle were not validated and the dry time for the Steam Pre-Vacuum 132 degree C (270 F) cycle was omitted..

Recalling firm

Bacterin International, Inc.

Classification

Class II

Status

Terminated

Initiated

2015-03-09

Terminated

2015-07-01

Firm location

Belgrade, MT, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.