Instrument Kit for use with OsteoSponge SC grafts — Class II medical device recall Z-1396-2015
Terminated recall by Bacterin International, Inc., reported 2015-04-15, distributed in AL, AR, AZ, CO, FL, GA, IL, IN…. Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel hav
| Recall number | Z-1396-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bacterin International, Inc., Belgrade, MT, United States |
| Recall initiated | 2015-03-09 |
| Classified | 2015-04-07 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2015-07-01 |
| Distributed | AL, AR, AZ, CO, FL, GA, IL, IN, LA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, PA, PR, TX, VA |
| Quantity | 63 units |
| Serial numbers | 004, 005, 006, 009, 010, 011, 012, 018, 019, 020, 021, 022, 023, 024, 025, 026, 029, 033, 036, 038, 040, 045, 048, 060, 063 and 37 more |
| Model numbers | 6508, 6511 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1396-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.