Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bo
FDA device recall Z-1396-2015 · posted 2015-04-07 · Terminated
Recall details
- Recalling firm
- Bacterin International, Inc.
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 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
- Date initiated
- 2015-03-09
- Date posted
- 2015-04-07
- Date terminated
- 2015-07-01
- Location
- Belgrade, MT
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