Z-1396-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2015
- Initiation Date
- March 9, 2015
- Termination Date
- July 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 units
Product Description
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.
Distribution Pattern
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.
Code Information
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.