Class 2 Device Recall Instrument Kit for use with OsteoSponge SC grafts

• Date Initiated by Firm: March 09, 2015
• Date Posted: April 07, 2015
• Recall Status: Terminated on July 01, 2015
• Recall Number: Z-1396-2015
• Recall Event ID: 70744
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• 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.
• Code Information: SERIAL NUMBERS: 004, 005, 006, 009, 010, 011, 012, 018, 019, 020, 021, 022, 023, 024, 025, 026, 029, 30, 033, 036, 038, 040, 045, 048, 060, 063, 064, 065, 066, 067, 068, 069, 070, 071, 072, 073, 074, 075, 076, 077, 079, 081, 082, 083, 084, 085, 086, 087, 088, 089, 090, 091, 092, 093, 094, 095, 096, 097, 098, 099, 100, 101, and 102.
• Recalling Firm/ Manufacturer: Bacterin International, Inc.; 600 Cruiser Ln; Belgrade MT 59714-9719
• For Additional Information Contact: Tasha Karlberg; 406-388-0480 Ext. 131
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: The firm, Bacterin, sent a "VOLUNTARY PRODUCT REMOVAL NOTIFICATION" letter and Steps for Voluntary Removal instructions, dated 03/03/2015, to their consignees on 3/9/2015. The letter described the product, problem and actions to be taken. The Consignees were instructed to check with your Inventory and Central Supply Departments to determine if you have the Instrument Kit for use with OsteoLock Facet Stabilization Dowel and BacFast HD Dowel listed; immediately remove all affected product and segregate the product in a secure location for return to Bacterin International, Inc.; complete and return the Tracking Verification Form to Bacterin (even if they do not have affected product to return) to listed address, by email tkarlberg@bacterin.com or fax to 1-406-388-3380; indicate returned products on tracking/verification form; contact the firm via email at tkarlberg@bacterin.com or call 1-406-388-0480 ext. 131 from 8am to 5pm Mountain Time to obtain instructions for returning the Instrument Kits to Bacterin; package the returned goods and send to Bacterin International, Inc. 664 Cruiser Lane, Belgrade, MT 59714. Consignees with further questions about recall, please call Regulator Affairs Manager at 406-388-9480 ext. 128 or send email to cming@bacterin.com
• Quantity in Commerce: 63 units
• Distribution: US Distribution in states of: Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, and Virginia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.