Bacterin OsteoSponge Instrument Kits Recalled for Sterilization Errors
Bacterin International is recalling 63 Instrument Kits for OsteoSponge SC grafts because the instructions for use contain incorrect sterilization parameters.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard involves incorrect sterilization instructions, which is a significant quality issue but does not involve reported injuries or deaths.
Plain-English summary
Bacterin International, Inc. is recalling 63 units of Instrument Kits used with OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel. The affected kits are used to insert grafts to fill bone defects in the subchondral region of articulating joints and to establish a port of entry for arthroscopic instruments. The recall involves part numbers 6508 and 6511.
The recall was initiated because the Instructions for Use (IFU) and the kit lids contain incorrect sterilization parameters. Specifically, the 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. These errors could affect the proper sterilization of the instruments.
The affected products were distributed in the United States, including 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. Users should check their inventory for the specific serial numbers listed in the recall notice and contact Bacterin International for instructions on how to return the affected kits.
The recalled product
- 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 instrumen
- Manufacturer
- Bacterin International, Inc.
- Affected units
- 63
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- SERIAL NUMBERS: 004
- 005
- 006
- 009
- 010
- 011
- 012
- 018
- 019
- 020
- 021
- 022
- 023
- 024
- 025
- 026
- 029
- 30
- 033
- 036
Distribution
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