Z-1396-2015Class II

Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts...

Name: Z-1396-2015 Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts...
Creator: Bacterin International, Inc.
Published: 2015-03-09
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2015-03-09 / Terminated / root cause: manufacturing process

FDA source

Bacterin International, Inc. began a recall of 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... on 2015-03-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1396-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-09
Posted: 2015-04-07
Terminated: 2015-07-01
Recalling firm: Xtant Medical Holdings, Inc.
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA root 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 [email protected] or fax to 1-406-388-3380; indicate returned products on tracking/verification form; contact the firm via email at [email protected] 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 [email protected]
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1396-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1396-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-07

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)