Reported Apr 15, 2015 · Terminated
Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill…
Bacterin International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bacterin International, Inc. · 600 Cruiser Ln · Belgrade, MT · 59714-9719
Is this the product you have?
- 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.
- Lot codes and dates
- SERIAL NUMBERS
63 of 63 codes
00400500600901001101201801902002102202302402502602930033036038040045048060063064065066067068069070071072073074075076077079081082083084085086087088089090091092093094095096097098099
- SERIAL NUMBERS
- Amount recalled
- 63 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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